Asklepios BioPharmaceutical (AskBio), a U.S.-based subsidiary of Bayer AG, is now one step closer to receiving U.S. Food and Drug Administration (FDA) approval for its one-time gene therapy for congestive heart failure.
AskBio and Bayer announced that AB-1002 has been granted the FDA’s fast track designation, which is designed to help accelerate the review process for drugs that treat “serious conditions and fill an unmet need.” This will ramp up the review process for AskBio and Bayer, ensuring they can meet and communicate with FDA representatives as needed.
AB-1002, also known as NAN-101, is designed to combat the impact of protein phosphatase 1, which has been linked to increasing a patient's risk of congestive heart failure. AskBio is currently enrolling patients for GenePHIT, a double-blinded, placebo-controlled, multi-center Phase II clinical trial designed to evaluate the safety and effectiveness of taking a single dose of AB-1002 via infusion to treat adult patients with non-ischemic cardiomyopathy and New York Heart Association (NYHA) Class III heart failure symptoms. Patients will receive either a high dose, a low dose or a placebo. The primary outcomes will be cardiovascular mortality, change in NYHA classification, left ventricular ejection fraction, peak oxygen update and six-minute walk test times.
“The FDA fast track designation for AB-1002 is an important accomplishment for the clinical development of this program and highlights our goal of potentially bringing effective treatments to patients with advanced congestive heart failure,” Canwen Jiang, MD, PhD, chief development officer and chief medical officer at AskBio, said in a statement. “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.”
Bayer acquired AskBio back in October 2020 for an upfront payment of $2 billion, with potential for another $2 billion based on certain milestones.
“In line with our purpose ‘science for a better life,’ we are committed to bringing significant improvements for patients through innovation,” Werner Baumann, Chairman of the Board of Management of Bayer AG, said at the time. “With this acquisition, Bayer significantly advances the establishment of a cell and gene therapy platform that can be at the forefront of breakthrough science contributing to, preventing, or even curing diseases caused by gene defects and further driving company growth in the future.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.