Carmell Therapeutics announced FDA clearance of an Investigational New Drug application for the company’s Bone Healing Accelerant (BHA). Carmell will begin enrolling patients in a pivotal study for long bone fractures to support a Biologics License Application. The company is on a path to be the first in the bone healing space with a BLA supported by two prospective, randomized, multicenter clinical studies demonstrating superiority to the standard of care.
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, wherein BHA demonstrated a significant reduction of infections vs. controls with no adverse reactions, a clear trend toward accelerated wound healing at 30 days and accelerated bone healing vs. controls. Healing acceleration was notably evident for the most severe type IIIA and IIIB open tibia fractures with extensive soft tissue injury.
The 220-patient multicenter, randomized, controlled, blinded study will evaluate the efficacy and safety of BHA vs. standard of care in subjects when applied to open tibia fractures. Open tibia fractures were chosen because healing rates are typically longer than for other bone fractures due to a higher risk of infection and the limited vascular supply and soft tissue coverage.
“Our IND clearance for our Bone Healing Accelerant, a combination biologic and device product, indicates Carmell has made significant progress in our level of biologic product knowledge, quality system implementation, and manufacturing process validation,” said Randy Hubbell, President and CEO.