The Food and Drug Administration (FDA) has granted a Fast Track designation to Carmell Therapeutics’ Bone Healing Accelerant (BHA), expediting and accelerating its Biologic License Application (BLA) approval.
BHA offers potential applications in dental implant surgery such as socket preservation and ridge augmentation as well as spine fusion and long-bone fractures, the company says.
Carmell Therapeutics expects BHA to be a more effective bone void filler by delivering growth factors that are released over weeks to grow stronger, denser, higher-quality bone, which it has now seen in preclinical models and in human clinical studies.
“Receiving expedited review allows for more frequent meetings with FDA to discuss our biologic’s development plan, reducing risk throughout our development process,” said Stephanie Kladakis, PhD, Carmell’s chief scientific officer.
“Also, this Fast Track designation allows for a rolling review for our Biologic License Application, which means that Carmell can submit sections of our BLA package for review by FDA as they are completed, rather than waiting until the entire application is complete as is usually required,” said Kladakis.
“This rolling review allows for a significantly shorter period for approval after clinical trial completion,” said Kladakis.
“Fast Track expedited review is awarded to aid in the development and expedite regulatory review of therapies which show promise in treating a serious or life-threatening medical condition and that address an unmet medical need,” said James Hart, MD, Carmell’s chief medical officer.
In December, the FDA cleared the company’s Investigational New Drug (IND) application for its first product, its BHA. This IND clearance enables Carmell to begin enrolling patients in a study for long bone fractures to support a BLA.
“Carmell Therapeutics is now on a path to be the first company in the bone healing space with a BLA supported by two prospective, randomized, multicenter clinical studies demonstrating superiority to the current standard of care,” said Donna Godward, Carnell Therapeutics’ chief quality officer.
“Pursuing a BLA approval for our Bone Healing Accelerant demonstrates Carmell’s commitment to the most robust and ultimately most commercially valuable regulatory pathway currently in the orthopedic/wound healing space,” said Godward.
Carmell’s BHA is regulated under the FDA’s Center for Biologics Evaluation and Research. The FDA accepted the data and the overall study design from the company’s double-arm, multicenter Phase II clinical trial of BHA in open tibia fractures.
In this study, BHA demonstrated a significant reduction of infections compared to controls, no adverse reactions, a clear trend toward accelerated wound healing at 30 days, and accelerated bone healing compared to controls, the company said.
The bone healing acceleration was especially evident for the most severe type IIIA and IIIB open tibia fractures with extensive soft tissue injury, Carmell said.
The first program for long bone fracture (trauma fixation) will result in a BLA that can be leveraged for dental since it is the exact same formulation, Carmell said, adding that it will see the most robust regulatory approval in the dental bone growth space.