AskBio Commences Phase II Trial To Treat Congestive Heart Failure

The start of GenePHIT (Gene Phosphatase Inhibition Therapy), a phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF), has been announced by Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company that is wholly owned and independently operated as a subsidiary of Bayer AG. 

GenePHIT is an adaptive, double-blind, placebo-controlled, randomized, multicenter trial to evaluate the safety and efficacy of a single intracoronary infusion of AB-1002 in adults with non-ischemic cardiomyopathy classified as New York Heart Association (NYHA) Class III Heart Failure who have been medically stable for at least 4 weeks, as per pharmmbiz.

A major step forward in the development of this innovative experimental gene therapy for patients with CHF who have a high unmet medical need has been reached with the advancement of AB-1002 into phase II.

Between 90 and 150 persons with a left ventricular ejection fraction of 15 to 35% who still have heart failure symptoms after following approved therapeutic guidelines will be included in GenePHIT. At 52 weeks, a modified win ratio of multiple clinically significant assessments serves as the main efficacy outcome.

“AskBio is excited to initiate GenePHIT under the leadership of Roger Hajjar, MD, scientific chair CHF, and Lothar Roessig, MD, integrated product team lead CHF,” said Jude Samulski, PhD, co-founder and chief scientific officer, AskBio. “We believe this trial will help determine the potential of AB-1002 as a treatment for one of the world’s most devastating diseases, and we look forward to learning more about this important investigational cardiac gene therapy. Our hope is that one day AB-1002 will potentially help patients suffering from congestive heart failure.”