Gene therapy to treat congestive heart failure gains FDA fast track designation
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Key takeaways:
- The FDA granted fast track designation to a one-time gene therapy for the treatment of congestive HF.
- The therapy is designed to inhibit protein phosphatase 1 and will be tested in the phase 2 GenePHIT trial.
Bayer AG and its subsidiary Asklepios BioPharmaceutical announced the FDA granted fast track designation for its investigational gene therapy for the treatment of congestive heart failure.
The fast track designation is granted to therapies with the potential to fill unmet needs of patients with serious medical conditions. It includes the ability for the developer to have more frequent interactions with the agency, and potentially future accelerated priority review and accelerated approval.
The investigational therapy (AB-1002, also known as NAN-101) is a one-time gene therapy administered to the heart and is designed to inhibit protein phosphatase 1, which is associated with congestive HF, according to a press release from the company.
The company is currently enrolling patients in the phase 2 gene phosphatase inhibition therapy (GenePHIT) trial to evaluate its safety and efficacy in patients with nonischemic cardiomyopathy and NYHA class III HF symptoms, according to the release.
“The fast track designation for AB-1002 emphasizes the need to rapidly advance new therapeutic modalities such as gene therapy for people living with congestive heart failure,” Christian Rommel, PhD, head of research and development at Bayer’s pharmaceutical division, said in the release. “This designation underpins the potential of AB-1002 to address [a] currently high unmet medical need, and we are excited about the opportunity to accelerate its development.”
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