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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData
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.
Editorial content is independently produced and follows the highest standards of journalistic integrity. Topic sponsors are not involved in the creation of editorial content.