Bayer AG and Asklepios BioPharmaceutical, (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for the AB-1002 programme.
AB-1002 is an investigational one-time gene therapy that’s administered to the heart to help promote the production of a constitutively active form of protein inhibitor 1 (I-1c) designed to block the action of protein phosphatase.1
Inhibiting the function of this protein, which is linked to congestive heart failure (CHF), could potentially lead to a therapeutic effect on the heart.
The purpose of the programme is to get important new therapeutics to patients earlier
The FDA Fast Track Programme is designed to facilitate the development and expedite the review of new therapeutics that are intended to treat serious conditions and fill unmet medical needs. Its purpose is to get important new therapeutics to patients earlier.
Therapeutics that receive this designation benefit from eligibility for more frequent meetings with the FDA to discuss the development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review.
“The Fast Track Designation for AB-1002 emphasises the need to rapidly advance new therapeutic modalities such as gene therapy for people living with congestive heart failure.” Said Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division. “Our Phase II GenePHIT clinical trial is currently enrolling patients with severe heart failure.”
AB-1002 is an investigational gene therapy that has not received marketing authorisation, and its efficacy and safety have not been established or fully evaluated.
AskBio is currently enrolling patients in the Phase II GenePHIT (Gene PHosphatase Inhibition Therapy) trial of AB-1002 (also known as NAN-101) for the treatment of CHF.
Reference
[1] Fish KM, Ladage D, Kawase Y, et al. AAV9.I-1c delivered via direct coronary infusion in a porcine model of heart failure improves contractility and mitigates adverse remodeling. Circ Heart Fail. 2013;6(2):310-317.