Drug Trial Delays Multiply

Akashi Therapeutics has halted a clinical trial of the Duchenne muscular dystrophy treatment HT-100 after a patient taking the highest dose of the drug experienced life-threatening health issues. The company noted that no other serious safety issues have been observed with HT-100, an anti-fibrosis agent, and it hopes to restart the study once it has investigated the cause of the patient’s decline. Separately, FDA has put a study of Medivation’s pidilizumab on partial clinical hold after the biotech discovered the cancer drug’s mechanism of action is unclear. Previously, pidilizumab was considered a PD-1 inhibitor, the same class as successful cancer treatments from Merck & Co. and Bristol-Myers Squibb.