BioCentury
ARTICLE | Clinical News

Akashi halts DMD program

January 27, 2016 1:47 AM UTC

Akashi Therapeutics Inc. (Cambridge, Mass.) said it suspended dosing and enrollment of all clinical studies of HT-100 to treat Duchenne muscular dystrophy after a patient experienced undisclosed "serious, life-threatening health issues." The patient had been receiving 60 ug/kg of HT-100 daily, the study's highest dose, for about two weeks in the dose-escalating Phase I/II HALO trial. Six patients have been dosed thus far in the 60 ug/kg cohort.

Akashi said it is holding discussions with FDA and investigating the possible causes of the patient's health issues. ...