Bayer and its subsidiary Asklepios BioPharmaceutical (AskBio) have commenced the Phase II Gene PHosphatase Inhibition Therapy (GenePHIT) clinical trial for investigational gene therapy AB-1002 to treat congestive heart failure (CHF).

The trial is designed to assess the efficacy and safety of the gene therapy in adults with non-ischemic cardiomyopathy, classified as NYHA Class III Heart Failure.

GenePHIT is a multicentre, double-blind, adaptive, placebo-controlled, randomised trial designed for evaluating a single intracoronary dose of AB-1002.

It aims to enrol adults who have been medically stable for a minimum of four weeks, with left ventricle ejection fraction ranging from 15 to 35%.

Participants who continue to experience heart failure symptoms in spite of treatment with recommended therapies will be part of the trial.

The trial’s primary efficacy goal involves a modified win ratio of various clinically relevant evaluation at 52 weeks.

It will also include a 52-week safety and primary efficacy period, followed by long-term follow-up of four years.

With recruitment progressing, AskBio intends to carry out the trial across the US and various European countries.

AskBio subsidiary Viralgen Vector Core is producing AB-1002, which is currently in the investigational stage.

The gene therapy is not yet approved by any regulatory agency with efficacy and safety not established currently. 

AskBio co-founder and chief scientific officer Jude Samulski said: “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 latest development comes after the companies reported that the Phase Ib clinical trial of AB-1005 gene therapy to treat Parkinson’s disease met the primary endpoint.

The data was reported after the companies concluded the 18-month data collection from the trial.