Bayer to present data from cardiovascular portfolio including late-breaking presentations from FIDELITY (Kerendia™) and first Phase 2b data from PACIFIC study program for oral Factor XIa inhibitor
Pre-specified subgroup analyses from FIDELITY explore the efficacy and safety of finerenone (Kerendia™) in primary and secondary prevention of cardiovascular (CV) and kidney outcomes in patients with a combination of cardiovascular disease, chronic kidney disease (CKD) and type 2 diabetes (T2D) / First Phase 2b PACIFIC trial, PACIFIC-AF, investigated the safety of asundexian versus apixaban in patients with atrial fibrillation / New XARENO study data reveals the impact of rivaroxaban (Xarelto™) in patients who have both non-valvular atrial fibrillation (NVAF) and advanced CKD / Analyses from the VICTORIA trial will provide insight into clinical benefit of vericiguat (Verquvo™) in patients with differing ejection fractions and worsening heart failure (HF) event types / The newly announced DISCOVERI program represents a comprehensive, dedicated investment in Verquvo. It unifies active and planned trials in generating new insights regarding the potential of Verquvo in HF
Not intended for U.S. and UK - Media American College of Cardiology’s 71st Annual Scientific Session (ACC.22):
Berlin, March 29, 2022 - Bayer will present a range of new clinical data at the American College of Cardiology's 71st Annual Scientific Session (ACC.22), 2-4 April, 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.
Kerendia FIDELITY study data:
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 the following late-breaking live-streamed session:
· Finerenone And Cardiorenal Outcomes By History Of Cardiovascular Disease In Patients With Type 2 Diabetes and Chronic Kidney Disease: FIDELITY Analyses
o Session 411 - Featured Clinical Research III
o April 4, 2022, 13:00 - 13:10 (EDT) / 19:00 - 19:10 (CEST)
The prespecified pooled analysis FIDELITY, including the FIDELIO-DKD and FIGARO-DKD studies, comprises the largest Phase 3 cardiorenal outcomes clinical trial program in >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.
Additional Kerendia study data:
A new subgroup analysis of FIGARO-DKD and FIDELIO-DKD, investigating the use and potential of Kerendia in relation to the population of the United States eligible for the treatment, will be presented during the following digital eAbstracts session:
· Generalizability Of FIGARO-DKD And FIDELIO-DKD Trial Criteria To The United States Population Eligible For Finerenone
o Session 1187 - Prevention and Health Promotion: Diabetes and Cardiometabolic Disease Digital Presentations
o April 2, 2022, 8:30 (EDT) / 14:30 (CEST)
Asundexian study data:
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. Results will be presented during the following Featured Clinical Research session:
· Multicenter, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel Group, Dose-finding Phase 2 Study Comparing The Safety Of The Oral FXIa Inhibitor Asundexian With Apixaban In Patients With Atrial Fibrillation: PACIFIC AF
o Session 407 - Featured Clinical Research II
o April 3, 2022, 12:15 - 12:25 (EDT) / 18:15 - 18:25 (CEST)
Xarelto study data:
Patients with advanced CKD have previously been excluded from randomized trials that investigate whether vitamin K antagonists (VKAs) or direct oral anticoagulants are more effective at treating non-valvular atrial fibrillation (NVAF). XARENO, a prospective real-world study, evaluated the effectiveness of rivaroxaban versus VKAs in NVAF patients with advanced CKD. Results will be presented during the following digital eAbstracts session:
· Real-World, Prospective Observational Study To Compare Rivaroxaban Versus Vitamin K Antagonist Treatment In Patients With Non-Valvular Atrial Fibrillation And Advanced Chronic Kidney Disease
o Session 1155 - Electrophysiology: Special Populations Digital Presentations
o April 2, 2022, 08:30 (EDT) / 14:30 (CEST)
Verquvo study data:
Further sub-analyses from the Phase 3 VICTORIA trial will provide new insights into the clinical benefit of Verquvo in HFrEF patients with differing ejection fractions and worsening heart failure event types:
· Ejection Fraction, Biomarkers, And Outcomes In Heart Failure With Reduced Ejection Fraction And The Impact Of Vericiguat On Outcomes In The Victoria Trial
o Session 2005 - Heart Failure and Cardiomyopathies: Clinical Science 13
o April 4, 2022, 09:45 - 10:30 (EDT) / 15:45 - 16:30 (CEST)
· Classification And Implications Of Heart Failure Events From The Victoria Trial
o Session 1114 - New Analyses from Heart Failure Clinical Trials
o April 4, 2022, 13:45 - 13:55 (EDT) / 19:45 - 19:55 (CEST)
An analysis of data from the Phase 2b study VITALITY-HFpEF will also explore whether frailty modulates health status in patients with heart failure with preserved ejection fraction (HFpEF):
· Does Frailty Modulate Health Status In Patients With Heart Failure And Preserved Ejection Fraction?
o Session 2005 - Heart Failure and Cardiomyopathies: Clinical Science 2005
o April 4, 2022, 09:45 - 10:30 (EDT) / 15:45 - 16:30 (CEST)
Vericiguat is co-developed with MSD (a tradename of Merck & Co, Kenilworth, NJ, USA) which holds commercial rights in the United States of America. In addition to ongoing analyses which continue to generate new insights into the use of vericiguat in patients following a worsening HF event based on VICTORIA, Bayer and MSD have comprehensively committed to dedicated investment into a full umbrella clinical research program titled DISCOVERI.
The comprehensive DISCOVERI program will expand understanding of the clinical utility of vericiguat, whilst exploring its use in heart failure patients beyond the criteria set in VICTORIA. The program will include, among others:
· VICTOR: A Phase 3 study exploring the efficacy of vericiguat in chronic heart failure patients with reduced ejection fraction of 40 percent or less who have not had a recent worsening heart failure event.
· VALOR: A Phase 3 study exploring the efficacy and safety of vericiguat in chronic heart failure pediatric patients with reduced ejection fraction of 40 percent or less between 28 days and <18 years of age.
· RIVER-HF: An innovative real-world database and analytics platform, developed in partnership with Aetion*, is already generating high quality real-world evidence (RWE) related to the impact of worsening HF events in several countries including the U.S., Germany, France, China, and Japan with planned further research specific to vericiguat. The objectives of the RIVER-HF platform are to:
o Further understand residual risk following a worsening HF event
o Clarify the distinct nature of the worsening HF patient population
o Gather insights on the clinical value of 'Verquvo', and to inform on both practical management and patient access
· Investigator-Initiated Research (IIR): A broad spectrum of investigator-initiated research addressing key areas addressing the mode of action of vericiguat, the impact of vericiguat on exercise and functional performance, as well as potential pleotropic effects in related disease areas.
Active trials from the DISCOVERI program are posted on clinicaltrials.gov.
*Aetion is a healthcare data science company which has been selected as a partner by the US Food and Drug Administration, the European Medicines Agency, and the UK’s National Institute for Health and Care Excellence to generate regulatory grade, scientifically valid real-world evidence (RWE).
Factor XI and FXIa Inhibitors (asundexian)
Asundexian (BAY2433334) is an oral Factor XIa (FXIa) inhibitor (anti-thrombotic) and is part of a portfolio of assets targeting FXI or FXIa currently in clinical development by Bayer. Asundexian is currently being studied in the PACIFIC Phase 2 clinical trial program that consists of three Phase 2b studies in over 4,000 patients with one of the following three medical conditions: atrial fibrillation (irregular heartbeat), a recent non-cardioembolic ischemic stroke or a recent myocardial infarction (heart attack). By specifically targeting a protein involved in pathological thrombus formation, but leaving the pathway involved in physiological vessel healing intact, inhibition of FXIa could have the potential to prevent events like stroke and myocardial infarction (MI) without a corresponding increase in bleeding risk. The asundexian clinical development program is designed to provide further support for this hypothesis. Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication.
More information about these trials is available at http://www.clinicaltrials.gov/. The National Clinical Trial numbers for these studies are PACIFIC-AF (atrial fibrillation) NCT04218266, PACIFIC-STROKE (non-cardioembolic ischemic stroke) NCT04304508 and PACIFIC-AMI (myocardial infarction) NCT04304534.
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