FDA Accepted Akan Bio’s IND Application
GERMANTOWN, Md., Feb. 16, 2021, Akan Biosciences, LLC (Akan), a Maryland-based, clinical-stage biotech company innovating cellular technology and proprietary manufacturing methods to produce stem cell-based therapeutics, today announced that the U.S. Food and Drug Administration (FDA) had accepted the Investigational New Drug Application (IND) for StroMel™, its lead candidate for the treatment of Osteoarthritis of Knee. The active IND enables Akan to start clinical trials.
StroMel™ is a proprietary adipose-derived Stromal Vascular Fraction (SVF) product. StroMel™ will be frozen and stored, allowing multiple administrations with each lot. Although the current IND is for autologous administration, Akan is planning to explore allogeneic applications as well.
StroMel™ would be a relatively unobtrusive therapy (intra-articular injections) for an indication described by the Arthritis Foundation as “a chronic disease … with no cure.” According to ABC News, medical care for osteoarthritis patients in the United States costs $185.5 billion a year.
The President of Akan, Dr. Mukesh Kumar, is a veteran of FDA-regulated products having taken hundreds of products through the FDA. Dr. Kumar commented that “StroMel™ is designed as an off-the-shelf SVF product direly needed by patients in the U.S. Our proprietary technology will eventually lead to a paradigm shift in the development and manufacturing of affordable cellular therapies.” The clinical trial is scheduled to initiate in March 2021.