Bayer to present data from CV-Portfolio, including a late-breaking presentation from FIDELITY (Kerendia™) and new Phase IIb data from PACIFIC trial program for the oral Factor XIa inhibitor asundexian

Berlin, August 22, 2022 – Bayer will present a range of new clinical data at the European Society of Cardiology Congress 2022 from 26-29 August. 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.

Kerendia FIDELITY study data:

The prespecified pooled analysis FIDELITY, including the FIDELIO-DKD and FIGARO-DKD studies, comprises data in >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.

New exploratory analysis of FIDELITY, investigating causes of mortality in patients with CKD and T2D treated with Kerendia or placebo, will be presented within the following late-breaking live-streamed session:

·       Finerenone and effects on mortality in chronic kidney disease and type 2 diabetes: A FIDELITY analysis

o   Hot Line: Hot Line Session 8 – Important Clinical Trial Updates

o   August 29, 09:24-09:42 CEST

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 U.S. if all eligible patients were treated with Kerendia. This sub-analysis will be presented during the following moderated ePosters session:

·       In patients with type 2 diabetes chronic kidney disease is a modifiable cardiovascular risk factor

o   Moderated ePosters: Diabetes and the heart 2

o   August 27, 10:15-11:00 CEST

Asundexian* PACIFIC Phase IIb study data:

The PACIFIC Phase II clinical program was designed to support the hypothesis that inhibiting Factor XIa (FXIa) with asundexian can reduce the risk of thrombotic events whilst minimizing additional bleeding risk. This program consists of separate clinical trials for three indications, detailed below.

PACIFIC-AMI is a Phase IIb dose-finding trial which compares the investigational, oral FXIa inhibitor asundexian to placebo on top of standard dual antiplatelet therapy in patients following an acute myocardial infarction (AMI, or heart attack). The study was designed to explore the effect of several different doses of asundexian on safety (bleeding) and efficacy (cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, and stent thrombosis) versus placebo, on top of dual anti-platelet therapy. The results of the study will be presented within the following late-breaker live-streamed session:

·       PACIFIC-AMI - Efficacy and safety of factor XIa inhibitor asundexian on top of dual antiplatelet therapy after acute myocardial infarction

o   Hot Line: Hot Line Session 5

o   28 August, 08:52-09:14 CEST

PACIFIC-STROKE is a Phase IIb dose-finding trial designed to explore the effect of several different doses of asundexian on safety (bleeding) and efficacy on top of the standard anti-platelet therapy in patients following a non-cardioembolic ischemic stroke compared to a placebo. The results of the study will be presented within the following late-breaker live-streamed session:

·       PACIFIC-STROKE - Phase II Program of AntiCoagulation via Inhibition of FXIa by the oral Compound BAY 2433334 – non-cardioembolic STROKE study

o   Hot Line: Hot Line Session 5

o   28 August, 09:14-09:36 CEST

PACIFIC-AF is a Phase IIb dose-finding study comparing the safety (bleeding) of the oral FXIa inhibitor asundexian to the non-vitamin K antagonist oral anticoagulant apixaban in patients with atrial fibrillation (AF) who are at risk of stroke. The results, previously presented in April at the ACC Congress 2022, 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. The 50 mg asundexian dose led to a near complete FXIa inhibition.

·       Safety of the oral Factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF)

o   Official Joint Session: Recent features from The Lancet

o   29 August, 14:37-14:56 CEST

An additional poster presentation on the complete bioavailability of asundexian will also be presented during the congress:

·       The complete bioavailability of asundexian is unaffected by tablet formulation, gastric pH, or food

o   Moderated ePosters: Vascular Biology and Physiology

o   29 August, 08:15-9:00 CEST

Verquvo study data:

Results from the proteomics sub-study of VITALITY-HFpEF, investigating if the unique clusters of circulating proteins are associated with specific clinical characteristics in patients with HFpEF will be presented during the following moderated ePosters session:

·       Targeted discovery proteomics to identify clinical phenotypes in heart failure with preserved ejection fraction: A proteomics sub-study of VITALITY-HFpEF

o   Abstract Sessions: HFpEF pathophysiology: new cardiac and peripheral mechanisms

o   26 August, 11:40-11:50 CEST

Geographic differences and background therapy in the global VICTORIA trial have been explored. These insights will be presented during the following moderated ePosters session:

·       Geographic variation in heart failure with reduced ejection fraction: Insights from the VICTORIA trial

o   Moderated ePosters: Heart failure with reduced ejection fraction (HFpEF)

o   27 August, 16:15-17:00 CEST

Data from the Swedish Heart Failure Registry will generate insights in a large and unselected real-world heart failure patient population. The analysis calculates the proportions of patients eligible for vericiguat according to trial, guideline, and labelling scenarios. It also compares eligible to ineligible populations for patient characteristics and outcomes. These insights will be presented during the following moderated ePosters session:

·       Real-world eligibility of vericiguat according to trial, guideline, and labelling eligibility criteria - Data from the Swedish Heart Failure Registry

o   Moderated ePosters: Heart failure pharmacology

o   28 August, 15:15-16:00 CEST

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 has been studied in the PACIFIC Phase IIb clinical trial program that consisted of three Phase IIb 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.

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.

*Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.

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