FIDELITY (Kerendia™) and new Phase IIb data from PACIFIC trial program for the oral Factor XIa inhibitor asundexian

Late-breaking data from a new exploratory analysis of FIDELITY investigating causes of mortality in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) treated with Kerendia™ (finerenone) or placebo / New Phase IIb data from PACIFIC trial program investigating the efficacy and safety of oral Factor XIa inhibitor asundexian versus placebo in stroke and acute myocardial infarction (AMI) / New vericiguat (Verquvo™) data from the proteomics sub-study of VITALITY-HFpEF, insights from the VICTORIA trial, and real-world eligibility findings from the Swedish Heart Failure Registry

Bayer will present a range of new clinical data at the European Society of Cardiology Congress 2022 from 26- 29 August. A aggregate of three late- breaking objectifications will be presented including data on thenon-steroidal, picky mineralocorticoid receptor( MR) antagonist finerenone( Kerendia ™), and the investigational oral Factor XIa asset, asundexian. fresh data on asundexian and the answerable guanylate cyclase stimulator( sGC) vericiguat( Verquvo ™) will also be presented, as well as seven donations about rivaroxaban including Hot Line, Late- Swell, and Bill sessions across a broad diapason of thrombosis suggestions. These data punctuate Bayer’s ongoing commitment to perfecting the lives of cases with cardiovascular( CV) and order conditions.

Kerendia FIDELITY study data
The prespecified pooled analysis FIDELITY, including the FIDELIO- DKD and FIGARO- DKD studies, comprises data in>,000 cases with habitual order complaint( CKD) and type 2 diabetes( T2D). dedication delved the efficacity and safety of Kerendia across a broad range of cases with early to late- stage CKD and T2D and handed perceptivity into the relationship between CKD stage( grounded on birth order complaint perfecting Global issues threat orders) and the goods of Kerendia on compound cardiovascular and order-specific endpoints.

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

· Finerenone and goods on mortality in habitual order complaint and type 2 diabetes A dedication analysis
o Hot Line Hot Line Session 8 – Important Clinical Trial Updates
o August 29, 0924- 0942 CEST

fresh data from FIDELITY will estimate whether CKD, as defined concertedly by estimated glomerular filtration rate( eGFR) and urine albumin- to- creatinine rate( UACR), is a adjustable cardiovascular( CV) threat factor in cases with T2D, assessing the population-wide reduction in first CV events in theU.S. if all eligible cases were treated with Kerendia. Thissub-analysis will be presented during the following moderated ePosters session

· In cases with type 2 diabetes habitual order complaint is a adjustable cardiovascular threat factor
o Moderated ePosters Diabetes and the heart 2
o August 27, 1015- 1100 CEST

Asundexian * PACIFIC Phase IIb study data
The PACIFIC Phase II clinical program was designed to support the thesis that inhibiting Factor XIa( FXIa) with asundexian can reduce the threat of thrombotic events whilst minimizing fresh bleeding threat. This program consists of separate clinical trials for three suggestions, detailed below.
PACIFIC- AMI is a Phase IIb cure- chancing trial which compares the investigational, oral FXIa asset asundexian to placebo on top of standard binary antiplatelet remedy in cases following an acute myocardial infarction( AMI, or heart attack). The study was designed to explore the effect of several different boluses of asundexian on safety( bleeding) and efficacity( cardiovascular death, myocardial infarction, ischemic or hemorrhagic stroke, and stent thrombosis) versus placebo, on top of binaryanti-platelet remedy.
Factor XI and FXIa Impediments( asundexian)
Asundexian( BAY2433334) is an oral Factor XIa( FXIa) asset(anti-thrombotic) and is part of a portfolio of means targeting FXI or FXIa presently in clinical development by Bayer. Asundexian has been studied in the PACIFIC Phase IIb clinical trial program that comported of three Phase IIb studies in over,000 cases with one of the following three medical conditions atrial fibrillation( irregular twinkle), a recentnon-cardioembolic ischemic stroke or a recent myocardial infarction( heart attack). By specifically targeting a protein involved in pathological thrombus conformation, but leaving the pathway involved in physiological vessel mending complete, inhibition of FXIa could have the eventuality to help events like stroke and myocardial infarction( MI) without a corresponding increase in bleeding threat. The asundexian clinical development program is designed to give farther support for this thesis.

further information about these trials is available at http// The National Clinical Trial figures 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 suggestion. About Bayer
    Bayer is a global enterprise with core capabilities in the life wisdom fields of health care and nutrition. Its products and services are designed to help people and earth thrive by supporting sweats to master the major challenges presented by a growing and growing global population. Bayer is committed to drive sustainable development and induce a positive impact with its businesses. At the same time, the Group aims to increase its earning power and produce value through invention and growth. The Bayer brand stands for trust, trustability and quality throughout the world. In financial 2021, the Group employed around,000 people and had deals of44.1 billion euros.

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