Carmell Therapeutics announced that the U.S. Food and Drug Administration (FDA) last month has cleared the company’s Investigational New Drug application (IND) for the company’s first product, a Bone Healing Accelerant (BHA). This IND clearance enables Carmell to begin enrolling patients in a pivotal study for long bone fractures to support a Biologics License Application (BLA).
“Receiving IND clearance to begin clinical trials is a key milestone in the development of our groundbreaking regenerative medicine platform technology,” said Randy Hubbell, Carmell Therapeutics’ President and CEO. “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.”
Carmell’s BHA is regulated under the U.S. 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 towards accelerated wound healing at 30 days, and accelerated bone healing compared to controls. The bone healing acceleration was especially evident for the most severe type IIIA and IIIB open tibia fractures with extensive soft tissue injury.
“This IND clearance is significant for us as the rigorous chemistry, controls and product manufacturing (CMC) requirements of the IND submission provide the framework for what will be submitted in the BLA application upon completion of the pivotal studies,” said Stephanie Kladakis, Ph.D., Carmell’s Chief Scientific Officer. “To meet these stringent requirements, our ISO 13485 certified manufacturing facility includes a Class 7 Cleanroom and we have successfully manufactured multiple batches of BHA, which have consistently passed strict finished-product and long-term stability testing.”
“Carmell is ready and eager to move into full testing of safety and efficacy of our Bone Healing Accelerant in large, randomized, clinical studies,” said Janet M. Vargo, Ph.D., Carmell’s Vice President of Clinical Sciences. “We will initiate enrollment for the approximately 220-patient study at 25 centers in the United States, Europe, and South Africa.”
The multi-region, multicenter, randomized, controlled, blinded study will evaluate the efficacy and safety of Carmell Therapeutics’ BHA versus standard of care in subjects when applied to tibia (leg bone) fractures with an external wound or skin break (also called open tibia fractures). The study is expected to enroll about 220 patients in 25 centers across the U.S., Europe, and South Africa. Open tibia fractures were chosen for this study because healing rates are typically longer than for other bone fractures due to the limited vascular supply, limited soft tissue coverage, and higher risk of infection. BHA active ingredients include blood-derived components and beta-tricalcium phosphate. It is applied directly to the bone fracture and nearby viable bone at the time of wound closure.
