BioCentury
ARTICLE | Clinical News

HT-100 regulatory update

March 24, 2017 8:17 PM UTC

FDA granted Akashi clearance to resume clinical development of Duchenne muscular dystrophy (DMD) candidate HT-100. The company said it plans to start a new Phase IIa trial “as quickly as possible.” In January 2016, Akashi suspended dosing and enrollment in all HT-100 trials after a patient in the Phase I/II HALO trial experienced “serious, life-threatening health issues." The patient later died. The new Phase IIa HALO-DMD-04 trial will evaluate once-daily dosing with 150 µg HT-100 and eliminate antiemetic use. Akashi said there was little or no antiemetic use in patients treated with once-daily 300-1,500 µg HT-100 in previous studies (see BioCentury, Feb. 22, 2016)...