BAY2413555 / Bayer - LARVOL DELTA

Safety and tolerability of the M2 muscarinic acetylcholine receptor modulator BAY 2413555 in heart failure with reduced ejection fraction in the REMOTE-HF study. (PubMed, Sci Rep) - "However, due to the limited number of subjects resulting from early termination, the results should be considered with caution and viewed as exploratory. There were promising signs of target engagement, providing grounds for further exploration of the mechanism."

Clinical • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Inflammation

Discovery of BAY 2413555, First Selective Positive Allosteric Modulator of the M2 Receptor to Restore Cardiac Autonomic Balance. (PubMed, J Med Chem) - "Extensive optimization of the screening hit in terms of potency, permeation, metabolic stability, and solubility ultimately resulted in the discovery of the first-in-class clinical candidate BAY 2413555 (27). With an overall technical profile compatible with once-daily oral administration in a phase 1 study, no apparent effects on blood pressure, and a mechanism that largely preserves autonomic regulatory capacity, BAY 2413555 could be the tool to finally study the restoration of autonomic balance."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure

REMOTE-HF: A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) (clinicaltrials.gov) - P1 | N=22 | Terminated | Sponsor: Bayer | Phase classification: P1b ➔ P1

Phase classification • Cardiovascular • Congestive Heart Failure • Heart Failure

REMOTE-HF: A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) (clinicaltrials.gov) - P1b | N=22 | Terminated | Sponsor: Bayer | N=129 ➔ 22 | Trial completion date: Sep 2023 ➔ Mar 2023 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2023 ➔ Mar 2023; Due to new preclinical findings in a chronic toxicology study.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Cardiovascular • Congestive Heart Failure • Heart Failure

REMOTE-HF: A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) (clinicaltrials.gov) - P1b | N=129 | Recruiting | Sponsor: Bayer | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Heart Failure

REMOTE-HF: A Study to Learn How Safe Study Drug BAY2413555 is, How it Affects the Body, and How it Moves Into, Through, and Out of the Body Over 4 Weeks of Use in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices (ICD/CRT) (clinicaltrials.gov) - P1b | N=129 | Not yet recruiting | Sponsor: Bayer

New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure