Akashi Therapeutics cleared to resume Duchenne candidate clinical development in USA

There was good news for US clinical-stage biotech Akashi Therapeutics yesterday, when it received permission to resume development of its Duchenne drug candidate.

The company said that the US Food and Drug Administration has completed its review and concluded that Akashi may resume clinical development of HT-100 (delayed-release halofuginone) in patients with any of the genetic mutations that cause Duchenne muscular dystrophy (DMD), a rare disease that results in muscle degeneration and premature death in boys. Akashi plans to initiate a new study, HALO-DMD-04.

Privately-held Akashi halted an early-stage trial of HT-100 in January 2016 after one patient experienced what the company called “serious, life-threatening health issues.” A week later, the company disclosed that the patient had died.