The pharma company is currently recruiting patients in the Phase 2 GenePHIT study to assess the safety and efficacy of the one-time administration of AB-1002
FDA grants fast track status to AskBio’s AB-1002 gene therapy candidate. (Credit: Pexels from Pixabay)
Bayer’s subsidiary Asklepios BioPharmaceutical (AskBio) has received fast track designation from the US Food and Drug Administration (FDA) for the AB-1002 gene therapy programme in congestive heart failure (CHF).
AB-1002, also known as NAN-101, is an investigational therapy given just once to the heart. It is designed to support heart function by stimulating the production of I-1c protein, which inhibits phosphatase 1 protein, a factor associated with congestive heart failure.
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 2 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.”
The FDA fast track programme aims to accelerate the process of developing and reviewing new treatments for serious conditions where there’s a lack of effective options. It aims to make these treatments available to patients sooner.
Under the programme, companies have more meetings with the FDA to plan the drug’s development, and if they meet certain criteria, they may also qualify for quicker approval processes like accelerated approval and priority review.
Bayer pharmaceuticals division research and development head Christian Rommel said: “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.
“This designation underpins the potential of AB-1002 to address currently high unmet medical need, and we are excited about the opportunity to accelerate its development.”
The efficacy and safety of the AB-1002 have not yet been determined or thoroughly examined.
Bayer’s subsidiary is currently recruiting patients in the Phase 2 GenePHIT study for the treatment of congestive heart failure using AB-1002.
The adaptive, double-blinded, placebo-controlled, randomised, multi-centre trial will assess the safety and efficacy of the one-time administration of the gene therapy candidate.
The preliminary data from the Phase 1 trial investigating AB-1002 showed clinically meaningful improvements in key efficacy parameters.