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Bayer announced on 20 Feb 2024 the start of a Phase II clinical trial (SIRIUS study) with BAY3018250, an investigational first-in-class anti-alpha2 antiplasmin (anti-a2ap) antibody in patients with deep vein thrombosis (DVT). The results of this study might provide evidence of anti-a2ap antibody's potential as a treatment option in indications of high medical relevance. Following the successful first-in-human trial, the goal of the randomized, double-blind, placebo-controlled, multi-centre Phase II study (SIRIUS study) is to assess the efficacy and safety of BAY3018250 in patients with symptomatic proximal deep vein thrombosis. BAY3018250 is designed to target alpha2 antiplasmin. a2ap's primary function is to inhibit the enzymatic activity of plasmin and thereby balance the formation and dissolution of blood clots. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2024., research and development; cardiovascular drugs; therapeutic antibodies; [...]

Bayer AG and Asklepios BioPharmaceutical Inc (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced on 13 Feb 2024 that the first patient has been randomized in GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF). GenePHIT is an adaptive, double-blind, placebo-controlled, randomized, multicentre trial to evaluate the safety and efficacy of a single intracoronary infusion of AB-1002 in adults with non-ischemic cardiomyopathy and New York Heart Association (NYHA) Class III heart failure symptoms who have been medically stable for at least four weeks. This milestone in the development of AB-1002 for the treatment of CHF potentially brings this investigational therapy one step closer to treating patients with high unmet medical need. GenePHIT will include between 90 and 150 adults with left ventricular ejection fraction between 15% and 35%, who continue to suffer from heart failure symptoms despite guideline recommended therapy. The primary efficacy endpoint at 52 weeks is a modified win ratio of several clinically meaningful assessments. AB-1002 is an investigational gene therapy that has not received marketing authorization, and its efficacy and safety have not been established or fully evaluated. AB-1002 is manufactured by Viralgen Vector Core SL, a wholly owned and independently operated subsidiary of AskBio. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2024., joint venture; research and development; cardiovascular drugs; gene therapies; Asklepios BioPharmaceutical (AskBio); [...]

Vividion Therapeutics Inc announced on 6 Feb 2024 that it has initiated dosing of patients in a Phase I clinical trial evaluating VVD-130850, an investigational oral STAT3 inhibitor for the treatment of advanced solid and haematologic tumours. Vividion is a biopharmaceutical company, and a wholly owned and independently operated subsidiary of Bayer AG, utilizing innovative discovery technologies with the potential to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders. The start of the trial represents another major milestone for Vividion's innovative chemoproteomics platform. VVD-130850 is an oral small molecule inhibitor of STAT3 binding to a novel allosteric pocket leading to direct inhibition of DNA binding and expression of STAT3 target genes in cancer cells. The Phase I clinical trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumour activity of VVD-130850 in patients with advanced solid and haematologic tumours as a single-agent and in combination with immune checkpoint inhibition. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2024., research and development; anticancer drugs; enzyme inhibitors; Bayer; Vividion [...]

Bayer AG and Asklepios BioPharmaceutical Inc (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, have announced the initiation of GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF). GenePHIT is an adaptive, double-blind, placebo-controlled, randomized, multicentre trial to evaluate the safety and efficacy of a single intracoronary infusion of AB-1002 in adults with non-ischemic cardiomyopathy classified as New York Heart Association (NYHA) Class III Heart Failure who have been medically stable for at least 4 weeks. The advancement of AB-1002 into Phase II marks a significant milestone for the development of this novel investigational gene therapy for patients with CHF who have high unmet medical need. GenePHIT will include between 90 and 150 adults with left ventricle ejection fraction between 15 and 35%, who continue to suffer from heart failure symptoms despite guideline recommended therapy. The primary efficacy endpoint at 52 weeks is a modified win ratio of several clinically meaningful assessments. AB-1002 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. AB-1002 is manufactured by Viralgen Vector Core, a wholly owned and independently operated subsidiary of AskBio. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2024., joint venture; research and development; cardiovascular drugs; enzyme inhibitors; gene therapies; Asklepios BioPharmaceutical (AskBio); Bayer; Viralgen Vector [...]

Bayer, a global leader in women's healthcare, announced on 8 Jan 2024 the expansion of the clinical development programme for the investigational compound elinzanetant. The first study participants were recently enrolled into NIRVANA, an exploratory Phase II study to evaluate the efficacy and safety of elinzanetant in women with sleep disturbances associated with menopause (SDM). The NIRVANA Phase II trial is a multi-centre, double-blind, randomized, parallel-group, placebo-controlled interventional study. It is intended to randomize approximately 78 participants in eight countries to investigate the efficacy and safety of elinzanetant in women with sleep disturbances associated with menopause (SDM). The primary endpoint for the NIRVANA study is the efficacy of elinzanetant on Wakefulness After Sleep Onset (WASO) at week 4 as measured by polysomnography. Additionally, Bayer announced positive topline results of the pivotal Phase III studies OASIS 1 and 2 evaluating the efficacy and safety of the investigational compound elinzanetant for the treatment of moderate to severe VMS associated with menopause versus placebo. Elinzanetant successfully met all four primary endpoints in both studies demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo. Both studies also achieved all three key secondary endpoints showing a statistically significant reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo. The safety profile observed in the OASIS 1 and 2 studies is overall consistent with previously published data on elinzanetant. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2024., research and development; elinzanetant; sleep disorder treatments; [...]

Asklepios BioPharmaceutical Inc (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced on 5 Jan 2024 that it is initiating GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase 2 trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF). GenePHIT is an adaptive, double-blind, placebo-controlled, randomized, multicentre trial to evaluate the safety and efficacy of a single intracoronary infusion of AB-1002 in adults with non-ischemic cardiomyopathy classified as New York Heart Association (NYHA) Class III Heart Failure who have been medically stable for at least 4 weeks. The advancement of AB-1002 into Phase 2 marks a significant milestone for this novel gene therapy for CHF and, if successful, could bring this important investigational therapy one step closer to treating patients with high unmet medical need. The GenePHIT trial, which includes 52-week safety and primary efficacy and four-year long-term follow-up periods, is currently recruiting. AskBio plans to conduct the trial in the US and multiple countries in Europe. AB-1002 is an investigational gene therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. AB-1002 is manufactured by Viralgen Vector Core, a wholly owned and independently operated subsidiary of AskBio. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2024., research and development; cardiovascular drugs; gene therapies; Asklepios BioPharmaceutical (AskBio); Bayer; Viralgen Vector [...]

Bayer AG and Asklepios BioPharmaceutical Inc (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced on 4 Jan 2024 the completion of the 18-month data collection in the Phase Ib clinical trial for AB-1005 (AAV2-GDNF), an investigational gene therapy for treating patients with Parkinson's disease (PD). The study met its primary objective, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putamen. Eleven patients were enrolled into two cohorts, Mild stage PD (6 patients) and Moderate stage PD (5 patients), based upon the timing from a PD diagnosis and the severity of their PD symptoms at screening. Neurosurgical delivery of AB-1005 was well tolerated by all patients with target putamen coverage of 63% plus-minus 2%, exceeding the goal of greater than 50% coverage with AB-1005. No serious adverse events have been attributed to AB-1005, with continued clinical follow-up for up to 5 years post administration ongoing. Patients also completed 18-month neurological assessments and self-reported questionnaires at regular intervals to evaluate the severity of motor and non-motor symptoms associated with PD. Additionally, brain imaging was performed to longitudinally assess safety and potential changes in dopamine handling or abnormal metabolic patterns associated with PD. AskBio is planning to present the 18-month study data, including secondary endpoints, at a scientific meeting in 2Q 2024. Planning is underway for a Phase II trial that is expected to begin screening patients in 1H 2024. The trial design has been harmonized with feedback from US and European health authorities. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2024., joint venture; research and development; gene therapies; Parkinson's disease treatments; Asklepios BioPharmaceutical (AskBio); [...]

Asklepios BioPharmaceutical Inc (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, on 12 Nov 2023 presented first-in-human data from a Phase 1 trial investigating AB-1002 (also known as NAN-101) for the treatment of patients with congestive heart failure (CHF) at the 2023 American Heart Association Scientific Sessions, which are being held in Philadelphia, PA, US, on 11-13 Nov 2023. The trial was designed to establish the safety and preliminary efficacy of gene therapy AB-1002 in patients with NYHA Class III Heart Failure, also known as advanced heart failure. AB-1002 is a rationally designed cardiotropic AAV vector targeting protein phosphatase inhibitor-1, which has been linked to heart failure. Single-dose administration of AB-1002 resulted in clinically meaningful improvements in key efficacy parameters. Among the six patients in Cohort 1, three who completed 12-month follow-up showed clinically meaningful improvements in left ventricular ejection fraction (LVEF), NYHA Functional Class (NYHA FC), Minnesota Living with Heart Failure Questionnaire (MLHFQ), cardiopulmonary exercise test (VO2 max), and 6-minute walk test (6MWT) at 12 months post-dose. The three remaining patients in Cohort 1 are still within the first 3 months post-injection. No treatment emergent adverse events (TEAEs) or serious adverse events (SAEs) were deemed related to study treatment. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2023., research and development; cardiovascular drugs; gene therapies; Asklepios BioPharmaceutical (AskBio); [...]

Vividion Therapeutics Inc announced on 18 Sep 2023 that it has initiated dosing of patients in a Phase I oncology clinical trial of its investigational oral Kelch-like ECH Associated Protein 1 (KEAP1) activator, VVD-130037. Vividion is a biopharmaceutical company utilizing novel discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders, and a wholly owned and independently operated subsidiary of Bayer AG. The start of the trial represents a major milestone for Vividion's innovative chemoproteomics platform. The company is advancing multiple novel biology programmes toward the clinic and has more than a dozen similar pipeline opportunities emerging in early discovery in the fields of oncology and immunology. The Phase I clinical trial will evaluate the safety, pharmacokinetics and pharmacodynamics and preliminary efficacy of VVD-130037 in patients with advanced solid tumours. Trial participants will have a histologically confirmed metastatic or unresectable solid tumour. Participants will receive ascending doses of VVD-130037, orally, once daily in 21-day treatment cycles. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2023., research and development; anticancer drugs; Bayer; Vividion [...]

Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, announced on 28 Jun 2023 positive top-line results from a Phase I clinical trial of investigational drug, bemdaneprocel (BRT-DA01), a potential first-in-class cell therapy for Parkinson's disease. The trial showed that bemdaneprocel was well-tolerated in all 12 patients in the study to date, with no major safety events. In addition, an assessment of the study's secondary endpoints demonstrated feasibility of transplantation and evidence of cell survival and engraftment in the brain through one year. Based on these results, planning is underway for a Phase II study that is expected to begin enrolling patients in 1H 2024. Bemdaneprocel (BRT-DA01), an investigational therapy comprised of dopamine producing neurons derived from pluripotent stem cells, is surgically implanted into the brain of a person with Parkinson's disease. When transplanted, these cells have the potential to reform neural networks that have been destroyed by Parkinson's disease in the hope of restoring motor and non-motor function to patients. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2023., joint venture; research and development; bemdaneprocel; Parkinson's disease treatments; stem cell therapies; Bayer; BlueRock [...]

Bayer, a global leader in radiology, has started the Phase III clinical development programme QUANTI, aiming to evaluate the efficacy and safety of gadoquatrane, a next-generation, extracellular, macrocyclic, gadolinium-based contrast agent (GBCA) for use in magnetic resonance imaging (MRI). Gadoquatrane is a highly stable MRI contrast agent featuring high relaxivity that has the potential to enable a substantially lower gadolinium (Gd) dose for patients. The QUANTI clinical development program encompasses two multinational Phase III studies, QUANTI CNS (central nervous system) and QUANTI OBR (other body regions), as well as one paediatric study, all investigating gadoquatrane at a dose of 0.04 mmol Gd/kg body weight (bw). This represents a gadolinium dose reduced by 60 percent in contrast-enhanced MRI compared to standard dosing of established products, which, if successfully tested, would constitute the lowest gadolinium dose for a multipurpose MRI contrast agent. Contrast-enhanced MRI plays a key role in the healthcare continuum, providing a radiation-free, non-invasive method of obtaining detailed images of the body, helping to distinguish and identify potential abnormalities within organs and tissues and supporting physicians in answering critical medical questions in the detection, characterization, and monitoring of disease. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2023., research and development; contrast media; gadolinium; gadoquatrane; imaging agents; [...]

Bayer announced on 22 Jun 2023 the initiation of FINE-ONE, a global, multicentre, randomized, placebo-controlled, double blind parallel-group Phase III study to evaluate the efficacy and safety of finerenone versus placebo in adults with chronic kidney disease (CKD) and type 1 diabetes (T1D). The primary objective of the study is to demonstrate superiority of finerenone over placebo in reducing urine albumin to creatinine ratio (UACR) over 6 months. Finerenone is marketed as Kerendia or, in some countries, as Firialta, and approved for the treatment of chronic kidney disease associated with type 2 diabetes (T2D) in more than 70 countries worldwide. In contrast to T2D, which is primarily a chronic metabolic disease, in type 1 diabetes the insulin secreting cells of the pancreas are destroyed, which is deemed to be attributable to factors such as genetics and environmental triggers. While T1D usually appears during childhood or adolescence, it can also develop in adults. CKD affects up to 40% of people with T1D. The prevalence of CKD due to T1D increased by 58.2% from 1990 to 2007 and by 21.7% from 2007 to 2017. The clinical course of CKD in people with T1D is characterized by an increased urinary albumin excretion rate, which is a first sign of kidney damage and may progress to macroalbuminuria and decrease in eGFR in later stages. Despite guideline-recommended therapies to control hyperglycaemia, hypertension, and albuminuria in people with type 1 diabetes, residual risk remains high with up to a quarter progressing to end-stage-kidney-disease and CKD being a leading cause of mortality in T1D. The planned study will investigate finerenone compared to placebo in addition to standard of care in approximately 220 adults with CKD and T1D. Individuals will be randomized in a 1:1 ratio to receive either finerenone or placebo in addition to standard of care, consisting of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme inhibitor (ACE) or an angiotensin II receptor blocker (ARB). Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2023., research and development; antidiabetics; enzyme inhibitors; finerenone; Firialta; Kerendia; kidney disorder treatments; [...]

Bayer will present new cardiorenal data from the comprehensive Kerendia (finerenone) clinical trial programme in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) at the 60th European Renal Association (ERA) congress 2023. This new data will include further insights from the FIDELITY prespecified pooled analysis on CKD progression, as well as new findings from the REKA and FINEGUST studies. A new post hoc analysis from FIDELITY will be presented at the 60th ERA congress, describing the validation of a previously developed lab-based risk prediction model, to accurately predict CKD progression in adults at all CKD stages. The post hoc analysis included all participants from the FIDELITY analysis, irrespective of estimated glomerular filtration rate (eGFR) or albuminuria stage. Bayer will also be providing an update on the FINEGUST study (EUPAS48148; NCT05526157), which is a multinational observational cohort study and part of the FOUNTAIN multi-database research platform. FINEGUST aims to describe drug utilization and temporal changes of different treatments in adults with CKD and T2D in two time periods (before and after finerenone approval) using secondary data from population-based data sources in Europe, Japan, China, the United Kingdom, and the United States (US). Bayer will present an evaluation of the occurrence of moderate to severe hyperkalaemia (HK) episodes among a large, representative sample of patients with CKD from the US between 2009 and 2020. To date, reported numbers on the epidemiology of HK in patients diagnosed with CKD vary significantly and are unclear in real-world patients across different CKD stages, eGFR and UACR strata. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2023., research and development; antidiabetics; finerenone; Kerendia; kidney disorder treatments; [...]

Bayer and its development partner MSD announced on 1 Jun 2023 that the first patient has been enrolled in the Phase II/III VALOR trial. VALOR will investigate the efficacy, safety, and pharmacokinetics of vericiguat (Verquvo) in paediatric patients aged above 28 days to 18 years with heart failure due to left ventricular systolic dysfunction. VALOR is the pivotal study in paediatric heart failure with vericiguat. Vericiguat is a soluble guanylate cyclase (sGC)-stimulator which significantly reduces the risk of cardiovascular death or hospitalization due to heart failure with reduced ejection fraction in adult patients who have had a recent worsening heart failure event. It specifically restores the deficient NO-sGC-cGMP pathway, which plays a critical role in the progression of heart failure. In the pivotal study VICTORIA, vericiguat has demonstrated efficacy on top of background heart failure therapy and is recommended for worsening chronic heart failure with reduced ejection fraction across major heart failure guidelines internationally (eg ESC-guideline recommendation class IIb). VALOR is a randomized, placebo-controlled, double-blind trial which enrols patients in more than 28 days through below 18 years of age with a history of symptomatic chronic heart failure resulting from systemic left ventricular systolic dysfunction and a reduced left ventricular ejection fraction. The primary endpoint is change in plasma concentration of N-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16. Vericiguat is being jointly developed with MSD. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2023., joint venture; research and development; cardiovascular drugs; vericiguat; Verquvo; Bayer; [...]

Bayer announced on 10 May 2023 the initiation of the phase III QUASAR study, designed to evaluate the efficacy and safety of aflibercept 8 mg dosed at extended treatment intervals compared to the standard of care, Eylea (aflibercept 2 mg) in macular oedema secondary to retinal vein occlusion (RVO). The QUASAR clinical trial will measure changes in best corrected visual acuity (BCVA) in patients who receive aflibercept 8 mg with extended treatment intervals after initial monthly doses and those who receive Eylea (aflibercept 2 mg) every 4 weeks, until the primary endpoint is assessed at week 36. Treatment intervals can be further extended after the week 36 timepoint. Aflibercept 8 mg has been developed with the aim to extend intervals between injections without compromising vision gains and safety. Eylea (aflibercept 2 mg) is the standard of care treatment for macular oedema secondary to RVO and is approved for central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO) in over 100 countries worldwide. The phase III QUASAR clinical trial in macular oedema secondary to RVO follows the application for regulatory authorization of aflibercept 8 mg in the EU, Japan, and other markets for the treatment of nAMD and DME. The submissions are based on positive efficacy and safety data from the phase III PULSAR trial in nAMD and the phase II/III PHOTON trial in DME, in which both studies met their primary endpoint of non-inferiority in BCVA at 48 weeks of aflibercept 8 mg with two extended dosing regimens (every 12 and every 16 weeks), compared to Eylea (aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses. Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea. Aflibercept 8 mg is investigational, and its safety and efficacy have not yet been fully evaluated by any regulatory authority. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2023., patents and technical know-how; regulations and rulings; research and development; aflibercept; Eylea; [...]

Following the enrolment of the first patient in Bayer's Phase III OCEANIC-AF clinical trial of asundexian, a potential anticoagulant for stroke prevention in atrial fibrillation (AF) patients, a healthcare analyst at GlobalData, a leading data and analytics company, offers her view. Asundexian is an oral inhibitor of Factor XIa (FXIa) that Bayer is developing as a potential treatment for prevention of stroke in atrial fibrillation, as well as for secondary prevention in patients with a non-cardioembolic ischaemic stroke asundexian or high-risk ischaemic attack. Asundexian was previously studied in the PACIFIC-AF Phase II clinical trial, which compared the safety of asundexian to Eliquis (apixaban), in patients with AF at increased risk for stroke. It was found that participants who received apixaban experienced severe bleeding that was three times higher than those receiving asundexian, supporting the theory that inhibition of FXIa preserves a patient's ability to clot in response to bleeding events. Following these encouraging findings, Bayer is now pressing ahead with its Phase III trial, OCEANIC-AF, which is designed to assess the safety, efficacy, and net clinical benefit associated with asundexian versus apixaban in a larger patient population over several years. The OCEANIC-AF trial could be critical for Bayer, especially as the patents of blockbuster anticoagulants, Eliquis and Xarelto, will expire later this decade, paving the way for asundexian to become a potential market leader in the future. Original source: Global Data, website: http://www.energy.globaldata.com, Copyright Global Data 2023., patents and technical know-how; research and development; anticoagulants; apixaban; apixaban; Asundexian; rivaroxaban; [...]

Bayer will present new renal and cardiovascular (CV) data from the comprehensive Kerendia (finerenone) clinical trial program in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) at the American Society of Nephrology's (ASN) Kidney Week 2022, on 1-6 Nov 2022. Four new sets of data will be presented including a late-breaking pooled, post-hoc analysis of FIDELITY, further analyses of FIDELIO-DKD, and the design of the first prospective observational study, FINE-REAL. The prespecified pooled analysis FIDELITY, including the FIDELIO-DKD and FIGARO-DKD studies, comprises data in above 13,000 patients with CKD and T2D. FIDELITY investigated the efficacy and safety of Kerendia across a broad range of patients with early to late-stage CKD and T2D, and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes - KDIGO - risk categories) and the effects of Kerendia on composite CV and kidney-specific endpoints. Late-breaking data from pooled, post-hoc analysis of FIDELITY will investigate the efficacy and safety of Kerendia in patients with CKD and T2D who have sustained an acute change in estimated glomerular filtration rate (eGFR). FIDELIO-DKD investigated the efficacy and safety of Kerendia in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5700 patients with CKD and T2D. Post-hoc analysis of the study will explore the cardiorenal effects of Kerendia in patients with CKD and T2D from Asia. FINE-REAL is the first prospective observational study with Kerendia in patients with CKD and T2D. The study is expected to provide insights into the use of Kerendia in routine clinical practice, and inform decision-making on initiating use of Kerendia in patients with CKD and T2D. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., research and development; antidiabetics; finerenone; Kerendia; kidney disorder treatments; [...]

Bayer announced on 28 Aug 2022 the start of a Phase III clinical development programme 'OCEANIC' to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor, as a potential new treatment in patients with atrial fibrillation and in patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. The initiation of the OCEANIC programme is based on the data from the Phase II PACIFIC programme. The PACIFIC-STROKE2 and PACIFIC-AMI3 Phase IIb trials compared the safety and efficacy of asundexian with placebo in patients following acute non-cardioembolic ischemic stroke or acute myocardial infarction (AMI), respectively. Both trials showed consistent safety results for asundexian comparable to placebo arm, regardless of background therapy. The data from the completed PACIFIC Phase IIb clinical trial programme, including previously published data from the PACIFIC-AF4 (atrial fibrillation) study, further support the hypothesis that asundexian may reduce the risk of thrombotic events without significantly impacting the risk of bleeding. The OCEANIC Phase III clinical development programme will start with two large multinational studies, OCEANIC-AF and OCEANIC-STROKE, expected to enrol up to 30,000 patients in over 40 countries. OCEANIC-AF will test asundexian against apixaban in patients with atrial fibrillation. The primary objective of OCEANIC-AF is to determine the effects on prevention of stroke and systemic embolism and, in addition, to show a lower risk for bleeding in patients receiving asundexian when compared to patients receiving apixaban. The first patients are expected to be enrolled later this 2022. OCEANIC-STROKE will be a placebo-controlled study on top of standard of care antiplatelet therapy in patients after a non-cardioembolic ischemic stroke or high-risk ischemic attack. The primary objective of the Phase III study OCEANIC-STROKE is to show a lower risk for ischemic stroke in comparison to placebo, without a significant increase in bleeding risk. By selectively modulating coagulation, the once-daily oral FXIa inhibitor asundexian is being investigated as a potential new treatment option in thrombosis prevention. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., research and development; apixaban; asundexian; cardiovascular drugs; stroke treatments; [...]

Asklepios BioPharmaceutical Inc (AskBio), a wholly owned and independently operated subsidiary of Bayer AG, has received clearance to conduct a Phase I/II trial for its novel Huntington's disease (HD) gene therapy, BV-101, in France through its subsidiary BrainVectis. This authorization, provided by the National Agency for Safety of Medicines and Health Products (ANSM), the country's governing drug authority, along with the approval of the trial protocol by the Ethics Committee in charge, enables the company to begin recruiting participants. BV-101 is a novel, exclusively designed adeno-associated virus (AAV) gene therapy vector that simultaneously addresses the metabolic dysfunction of diseased neurons as well as contributes to the clearance of the mutant huntingtin protein. BV-101 is administered through MRI-guided neurosurgical techniques directed to target tissues in the basal structures of the brain. In preclinical studies in mice, BV-101 demonstrated the ability to repair the essential cholesterol pathway, provide neuroprotection, and restore physical performance by delivering CYP46A1, a crucial enzyme in the brain which is reduced in people with HD. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., regulations and rulings; research and development; gene therapies; huntington's disease treatments; Asklepios BioPharmaceutical (AskBio); Bayer; [...]

Bayer will present a range of new clinical data at the European Society of Cardiology Congress 2022 on 26-29 Aug 2022. A total of three late-breaking abstracts will be presented including data on the non-steroidal, selective mineralocorticoid receptor (MR) antagonist finerenone (Kerendia), and the investigational oral Factor XIa inhibitor, asundexian. Additional data on asundexian and the soluble guanylate cyclase stimulator (sGC) vericiguat (Verquvo) will also be presented, as well as seven presentations about rivaroxaban including Hot Line, Late-Breaker, and Poster sessions across a broad spectrum of thrombosis indications. These data highlight Bayer's ongoing commitment to improving the lives of patients with cardiovascular (CV) and kidney diseases. The prespecified pooled analysis FIDELITY, including the FIDELIO-DKD and FIGARO-DKD studies, comprises data in above 13,000 patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). FIDELITY investigated the efficacy and safety of Kerendia across a broad range of patients with early to late-stage CKD and T2D and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes risk categories) and the effects of Kerendia on composite cardiovascular and kidney-specific endpoints. Additional data from FIDELITY will evaluate whether CKD, as defined jointly by estimated glomerular filtration rate (eGFR) and urine albumin-to-creatinine ratio (UACR), is a modifiable cardiovascular (CV) risk factor in patients with T2D, assessing the population-wide reduction in first CV events in the US if all eligible patients were treated with Kerendia. Other study results are presented. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., research and development; antidiabetics; asundexian; cardiovascular drugs; finerenone; Kerendia; kidney disorder treatments; rivaroxaban; vericiguat; Verquvo; [...]

Bayer announced on 28 Jul 2022 the completion of two Phase 2b clinical trials: the RE-THINC ESRD trial and the CONVERT trial. The RE-THINC ESRD trial evaluated the safety of fesomersen, Bayer's investigational, subcutaneously administered ligand-conjugated antisense (LICA) oligonucleotide, in patients with end-stage renal disease (ESRD) on haemodialysis. The CONVERT trial evaluated the safety and tolerability of osocimab, Bayer's investigational, subcutaneously administered human monoclonal IgG1 antibody in patients with ESRD on haemodialysis. The data from both trials will be presented at an upcoming scientific meeting. Fesomersen and osocimab are investigational agents and have not been approved for use in any country, for any indication. Fesomersen was discovered and initially developed by Ionis Pharmaceutical Inc who has granted Bayer an exclusive licence to further develop and commercialize the compound. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., patents and technical know-how; research and development; antisense oligonucleotides; fesomersen; kidney disorder treatments; monoclonal antibodies; osocimab; therapeutic antibodies; Bayer; Ionis [...]

Bayer will present new renal and cardiovascular data from the comprehensive Kerendia (finerenone) clinical trial program at the 2022 American Diabetes Association (ADA) 82nd Scientific Sessions. This new data will comprise of further insights from FIDELITY, including late-breaking data from a new post-hoc analysis, as well as retrospective findings from FIDELIO-DKD and FIGARO-DKD. The prespecified pooled analysis FIDELITY, including the Phase III studies FIDELIO-DKD and FIGARO-DKD, comprises the largest Phase III cardiorenal outcomes clinical trial program investigating cardiorenal outcomes in more than 13,000 patients with CKD and T2D. Data from a new post-hoc analysis from FIDELITY will investigate the effect of finerenone by baseline HbA1c categories, HbA1c variability, and diabetes duration in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). Despite well-controlled blood glucose levels and blood pressure, many patients with CKD and diabetes still progress to loss of kidney function. New strategies are needed to prevent further end-organ damage and slow patient's rate of decline in kidney function. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., research and development; antidiabetics; finerenone; Kerendia; kidney disorder treatments; [...]

BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer AG, announced?the completion of enrolment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson's disease (PD). The purpose of the?Ph1 clinical trial is to evaluate the safety, tolerability, and?preliminary?efficacy?of BRT-DA01 in patients with Parkinson's disease.? Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., research and development; Parkinson's disease treatments; Bayer; BlueRock [...]

Bayer will present new renal and cardiovascular data from the comprehensive Kerendia (finerenone) clinical trial programme at the 59th European Renal Association (ERA) congress 2022. This new data will include further insights from the FIDELITY prespecified pooled analysis, as well as new findings comparing finerenone outcomes from FIDELIO-DKD with outcomes from CREDENCE. A new subgroup analysis from FIDELITY will be presented at the 59th ERA congress, investigating the efficacy and safety of finerenone in patients with stage 4 CKD and T2D compared to patients with stage 1-3 CKD and T2D. In addition, Bayer will showcase a new post hoc FIDELITY analysis, evaluating the effects of Kerendia, a non-steroidal, selective mineralocorticoid receptor antagonist, in comparison with the steroidal mineralocorticoid receptor antagonist spironolactone (Aldactone) plus potassium binding agent, patiromer (Veltassa) on serum potassium [(K+)] outcomes and discontinuations in a subgroup of patients that meet the eligibility criteria of the Phase II AMBER study. The AMBER study investigated the effects of spironolactone plus patiromer in 295 participants. Bayer will present new matching-adjusted indirect comparison data of FIDELIO-DKD and the Phase III CREDENCE study. FIDELIO-DKD investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on renal and cardiovascular outcomes in approximately 5700 patients with CKD and T2D. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., research and development; antidiabetics; binding agents; finerenone; Kerendia; kidney disorder treatments; patiromer; spironolactone; spironolactone; Veltassa; [...]

Bayer announced on 3 Apr 2022 the positive data from the PACFIC-AF trial which compared the safety of the investigational, oral Factor XIa (FXIa) inhibitor asundexian with apixaban (a non-vitamin K antagonist oral anticoagulant) in patients with atrial fibrillation (AF). The results found that the bleeding rate for the primary endpoint (ISTH major and clinically relevant non-major bleeding) was reduced by 67% (incidence proportion of 0.33) in patients receiving asundexian compared to those receiving apixaban. By selectively modulating coagulation, once-daily FXIa inhibitor asundexian is being investigated to become a new treatment option in thrombosis prevention. The findings were presented on 3 Apr 2022 at the American College of Cardiology's 71st Annual Scientific Session (ACC.22), and simultaneously published in The Lancet. PACIFIC-AF is the first head-to-head trial to compare the bleeding risk of an oral FXIa inhibitor vs a non-vitamin K antagonist oral anticoagulant (NOAC) in patients with AF who are at risk of stroke. The trial's primary objective was to determine whether treatment with asundexian can lead to a lower incidence of ISTH major and clinically relevant non-major bleeding when compared with apixaban in patients with AF. It also aimed to determine the optimal dose of asundexian, 20 mg or 50 mg once-daily, in these patients. This trial was not powered to discern or test differences in the rates of thrombotic events. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., research and development; anticoagulants; apixaban; asundexian; cardiovascular drugs; [...]

Bayer will present a range of new clinical data at the American College of Cardiology's 71st Annual Scientific Session (ACC.22), 2-4 Apr 2022, including data on the non-steroidal, selective mineralocorticoid receptor (MR) antagonist, finerenone (Kerendia); the soluble guanylate cyclase stimulator (sGC), vericiguat (Verquvo); the Factor Xa inhibitor, rivaroxaban (Xarelto); and the investigational oral Factor XIa inhibitor, asundexian. These data highlight Bayer's ongoing commitment to improving the lives of patients with cardiovascular (CV) and kidney diseases. New pre-specified subgroup analyses of FIDELITY, investigating the efficacy and safety of Kerendia in primary and secondary prevention of CV and kidney outcomes in patients with a combination of cardiovascular disease, chronic kidney disease (CKD) and type 2 diabetes (T2D), will be presented within a late-breaking live-streamed session. The prespecified pooled analysis FIDELITY, including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase 3 cardiorenal outcomes clinical trial programme in more than 13,000 patients with CKD and T2D. FIDELITY investigated the efficacy and safety of Kerendia across the spectrum of patients with CKD and T2D and provided insights into the relationship between CKD stage (based on baseline Kidney Disease: Improving Global Outcomes risk categories) and the effects of Kerendia on composite cardiovascular and kidney-specific endpoints. PACIFIC-AF is the first head-to-head study to compare the bleeding safety of an oral FXIa inhibitor versus a non-vitamin K oral anticoagulant (NOAC) in patients with atrial fibrillation (AF) who are at risk of stroke. The study's primary objective was to determine whether treatment with asundexian leads to a lower incidence of bleeding when compared with apixaban in patients with AF. It also aimed to determine the optimal dose of asundexian in these patients. Other study results are provided. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., research and development; anticoagulants; antidiabetics; asundexian; cardiovascular drugs; finerenone; Kerendia; kidney disorder treatments; rivaroxaban; rivaroxaban; vericiguat; Verquvo; [...]

At the 2022 ASCO GU Cancers Symposium Bayer presented results from the Phase III ARASENS trial which demonstrated that the use of the oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and docetaxel significantly increased overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to ADT plus docetaxel. Darolutamide plus ADT and docetaxel significantly reduced the risk of death by 32.5% compared to ADT plus docetaxel (HR=0.68, 95% CI 0.57-0.80; P below 0.001). At the data cutoff date for the primary analysis (25 Oct 2021), the median treatment duration was longer for darolutamide plus ADT and docetaxel (41.0 months) versus ADT plus docetaxel (16.7 months). Amid these positive results Bayer raised peak sales expectation for Nubeqa (darolutamide) to exceed EUR 3 bn. Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. Based on results from the pivotal Phase III ARAMIS trial, the compound is already approved for the treatment of patients with nmCRPC, who are at high risk of developing metastatic disease, in more than 60 markets worldwide. Results from the second Phase III ARASENS trial evaluating darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC) were presented on 16 Feb 2022 as an oral presentation at the 2022 ASCO GU Cancer Symposium and simultaneously published in The New England Journal of Medicine. Bayer is already in discussions with health authorities worldwide regarding the submission for marketing authorization in this additional indication. Darolutamide is being investigated in a broad development programme with additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease. This includes another Phase III trial in mHSPC (ARANOTE) as well as an ANZUP-led international co-operative group Phase III trial, evaluating darolutamide as an adjuvant treatment for localized prostate cancer with very high risk of recurrence (DASL-HiCaP, ANZUP1801). In addition, a study to explore the potential of darolutamide in the early setting for patients who have been treated with surgery or radiation and now see a rise in their prostate specific antigen (PSA) levels is also planned. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., joint venture; research and development; sales; anticancer drugs; darolutamide; docetaxel; Nubeqa; Bayer; [...]

Bayer announced on 10 Feb 2022 that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment for secondary prevention in patients with a non-cardioembolic ischaemic stroke. Asundexian is an oral inhibitor of Factor XIa (FXIa) that Bayer is developing as a potential treatment for secondary prevention in patients with a non-cardioembolic ischemic stroke as well as for two additional conditions: atrial fibrillation (irregular heartbeat) and recent myocardial infarction (heart attack). Asundexian is currently in Phase II clinical trials in all three indications either as a standalone therapy, or in combination with anti-platelet therapy. Inhibition of FXIa by asundexian is hypothesized to provide protection from thrombotic events without increasing the risk of bleeding. Fast Track Designation is intended to facilitate the development and expedite the review of drug candidates to treat serious medical conditions and fulfil unmet medical needs. The purpose of the program is to get important new therapeutics to the patient earlier. A drug candidate that receives Fast Track Designation may be eligible for more frequent interactions with the US FDA to discuss the drug candidate's development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review. Original source: Bayer, website:http://www.bayer.com/, Copyright Bayer AG 2022., regulations and rulings; research and development; asundexian; stroke treatments; [...]

BlueRock Therapeutics, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer AG, announced the closeout of the first of two cohorts in its ongoing Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with advanced Parkinson's disease. The purpose of the Ph1 clinical trial is to evaluate the safety, tolerability and preliminary efficacy of DA01 in patients with Parkinson's disease. Enrolment of the first cohort of patients was completed at three active sites in the United States and Canada: Weill Cornell Medicine, University of California, Irvine and University Health Network. Patients in the first cohort received a bilateral surgery to transplant dopaminergic neurons in the midbrain region. No severe adverse events were observed in any participating patients. Original source: Bayer, website: http://www.bayer.com/, Copyright Bayer AG 2022., research and development; Parkinson's disease treatments; stem cell therapies; Bayer; BlueRock [...]

Algeta ASA announced that data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial of its drug Xofigo (radium Ra 223 dichloride) in castration-resistant prostate cancer (CRPC) [...]

Bayer has initiated a Phase III trial to study a new Factor VIII product. The PROTECT VIII trial investigate whether prophylactic administration of BAY 94-9027 can maintain protection against bleeding [...]

On 23 Jul 2012, Bayer HealthCare, Onyx Pharmaceuticals, Inc. and Astellas Pharma Inc announced that a Phase III trial evaluating the efficacy and safety of the addition of Tarceva (erlotinib) [...]

On 4 Jun 2012, Bayer HealthCare announced that updated data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial for its investigational drug Alpharadin (radium-223 dichloride) confirm [...]

On 4 Jun 2012, Bayer HealthCare announced positive data from the Phase III GRID (GIST - Regorafenib In Progressive Disease) trial evaluating its investigational drug regorafenib in patients with metastatic [...]

On 25 Apr 2012, Bayer AG announced the successful completion of two pivotal European Phase III clinical trials with ATX-101, an injectable drug for the reduction of unwanted fat under [...]

German chemical and pharmaceutical company Bayer AG has agreed with Amgen Inc to develop and commercialise a new antibody for treating cancer. Bayer will collaborate with Amgen at its Munich [...]

On 3 Apr 2012, Bayer HealthCare announced positive results from its Phase III trial GRID (GIST - Regorafenib In Progressive Disease) evaluating its investigational compound regorafenib (BAY 73-4506) for the [...]