The US Food and Drug Administration (FDA) has granted fast-track designation to Bayer subsidiary Asklepios BioPharmaceutical’s (AskBio) investigational gene therapy AB-1002, aimed at treating congestive heart failure (CHF).
This designation is poised to expedite the development and review process of AB-1002, potentially bringing this one-time therapy to patients sooner.
AB-1002 works by enhancing the production of a constitutively active form of protein inhibitor 1 in the heart to hinder the action of protein phosphatase 1, a protein linked to CHF.
The Fast Track programme aids in quickening the development and review of new therapeutics that address serious conditions and fulfil unmet medical needs.
Furthermore, therapies receiving this status could benefit from more frequent interactions with the US regulator regarding their development plan.
Such therapeutics could also be eligible to receive accelerated approval and priority review if they meet certain criteria.
Currently, AskBio is enrolling participants in the Phase II GenePHIT trial of AB-1002, focusing on the treatment of CHF.
This adaptive, double-blinded, placebo-controlled, randomised, multicentre trial aims to assess the safety and efficacy of a one-time dose of AB-1002.
In the trial, the therapy will be delivered through antegrade intracoronary artery infusion to both male and female patients aged over 18 years with non-ischemic cardiomyopathy and New York Heart Association (NYHA) Class III heart failure symptoms.
Cardiovascular-related mortality and changes from baseline in NYHA classification, left ventricular ejection fraction, peak oxygen uptake, and performance in the Six Minute Walk Test will be the trial’s primary outcome measures.
AskBio chief development officer and chief medical officer Canwen Jiang said: “The FDA fast track designation for AB-1002 is an important accomplishment for the clinical development of this programme and highlights our goal of potentially bringing effective treatments to patients with advanced congestive heart failure.
“We look forward to completing our Phase II GenePHIT clinical trial, which is currently enrolling patients with severe heart failure, and are committed to exploring the full potential of AB-1002 for the treatment of this devastating disease.”
