GenePHIT, which is now enrolling, will study AB-1002 in adults with NYHA Class III Heart Failure and non-ischemic cardiomyopathy
GenePHIT is an adaptive, double-blind, placebo-controlled, randomised, multicenter trial. (Credit: Ali Hajiluyi on Unsplash)
Asklepios BioPharmaceutical, a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that it is initiating GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase 2 trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).
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.
The advancement of AB-1002 into Phase 2 marks a significant milestone for this novel gene therapy for CHF and, if successful, could bring this important investigational therapy one step closer to treating patients with high unmet medical need.
GenePHIT will include between 90 and 150 adults with left ventricle ejection fraction between 15 and 35%, who continue to suffer from heart failure symptoms despite guideline recommended therapy. The primary efficacy endpoint at 52 weeks is a modified win ratio of several clinically meaningful assessments.
“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.”
The GenePHIT trial, which includes 52-week safety and primary efficacy and four-year long-term follow-up periods, is currently recruiting. AskBio plans to conduct the trial in the U.S. and multiple countries in Europe.
Source: Company Press Release