Short-term, Carmell plans to build on the success of the completed First-In-Human (Phase II) study of Bone Healing Accelerant (BHA) for long bone fractures. In this study, reduced infections, accelerated bone healing, and more rapid wound closure were observed.
BHA is an investigational product and is currently classified as a biologic/device combination product by the FDA and has been assigned to the Center for Biologics Evaluation and Research (“CBER”) as the lead agency center for review and regulation.
Carmell Therapeutics has had substantial success advancing the lead program through the FDA regulatory process, which includes Chemical, Manufacturing and Controls (CMC) section and a Phase II clinical trial protocol. There are two major steps to the manufacturing of BHA: Drug Substance (aka “active ingredient”) and Drug Product (aka “finished product”). Both have been reviewed and cleared for a pivotal (late-stage) clinical study, HEAL II by FDA as part of IND 18789. Also, FDA granted the Company an expedited review “Fast Track” - Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The process is designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.
In Europe, the European Medicines Agency (EMA) has designated BHA as a "Class III" medical device. The company plans to pursue a CE mark with an anticipated label as a bone void filler. Our plans are subject to discussion with the EMA.
We are currently focused on accelerated bone healing in severe open tibia fractures and other applications where there are need for healing bone fractures, bone defects or need for bone fusion. The product formulation for these applications is a combination product containing the Company’s proprietary PBM technology and β-TCP. Leveraging the resources of investors and strategic vendors, we have successfully surpassed multiple critical milestones:
While the platform technology of PBM is initially targeted to accelerate and enhance healing in bone applications, in keeping with our exclusive license agreement, we believe PBM has the ability to deliver many regenerative factors, including the important GFs directly to the area in need of enhanced tissue healing. Promising results in both animal testing and human clinical studies position the core technology for potential use in a variety of therapeutic areas.