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AskBio’s AB-1002 gene therapy receives FDA Fast-Track status

AskBio’s AB-1002 gene therapy receives FDA Fast-Track status

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.

April 22, 2024

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