FDA grants Fast Track designation to Akashi Therapeutics' HT-100 for treatment of DMD

Akashi Therapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company's most advanced product candidate, HT-100 (delayed-release halofuginone), an orally available, small molecule drug candidate intended to reduce fibrosis and inflammation and promote healthy muscle regeneration in boys with DMD. Fast track designation is granted by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

"We are pleased that the FDA supports our application for fast track designation for HT-100 for the treatment of DMD. This, along with the previously granted orphan drug designation for HT-100, is an important regulatory milestone for the program," said Marc B. Blaustein, CEO of Akashi Therapeutics. "We will continue to work closely with the FDA as we advance HT-100 through clinical development and the associated regulatory processes."

Akashi is currently treating patients with DMD in a phase 1b/2a multi-center clinical program to evaluate HT-100 safety and tolerability and assess trends in a range of exploratory biomarkers and efficacy endpoints.