Bucindolol

Published

dm+d

Unassigned

New Medicines

GencaroAtrial fibrillation (AF) - with heart failure and/or left ventricular dysfunction

Information

Gencaro
Licence extension / variation
ARCA
ARCA

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials
Aug 20Initiation of PIII PRECISION-AF trial on hold due to COVID-19 pandemic. Enrolment could start in 2021, but any future development of bucindolol including initiating any PIII trails is dependent on obtaining additional financing [7]
Aug 19ARCA biopharma announces it plans to initiate the PIII PRECISION-AF clinical trial in the first quarter of 2020. The target trial population has been expanded to include HF patients with LVEF >40% and < 55% [6].
Dec 18PIII PRECISION-AF trial planned to start in Jul 19 [5]


Aug 17, ARCA announces the DSMB conducted a pre-specified interim analysis of the Phase IIb/III GENETIC-AF trial and recommended completion with no changes to the design, based on its efficacy and safety review - the data did not support immediate transition of the trial to Phase III.


Apr 15. FDA grants fast track designation to Gencaro for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population.

Category

beta-blocker and mild vasodilator
Atrial fibrillation (AF) - with heart failure and/or left ventricular dysfunction
Oral

Trial or other data

Feb 18: Positive results from PIIb GENETIC-AF trial (n=267) announced in pts with AF. However, the company focussed on positive data from subgroup analyses rather than the overall population in the trial. In all pts, Gencaro demonstrated a similar treatment benefit vs. TOPROL-XL (metoprolol succinate). There were 143 total events, hazard ratio of 1.01 (95% confidence interval: 0.71, 1.42). All pts showed a similar benefit compared to the active control, metoprolol succinate. Gencaro did not show superiority overall, which was the goal of the trial. Furthermore, the trial was not powered to conventional significance for its endpoint. Safety data indicated that Gencaro was generally safe and well-tolerated in the AF/heart failure (HF) population investigated with a safety profile similar to TOPROL-XL. The company plans to work with the towards PIII trials.[4]


April 14: First patient has been genetically screened in GENETIC-AF, Phase 2B/3 adaptive design clinical trial. The GENETIC-AF trial will evaluate bucindolol hydrochloride as a potential treatment for the prevention of atrial fibrillation (AF) in patients with heart failure and/or left ventricular dysfunction who also have a specific genotype of the beta-1 adrenergic receptor (389 arginine homozygous)