Akashi suspends HALO trial for Duchenne candidate on safety grounds
In another blow for the Duchenne community, privately-held US biotech firm Akashi Therapeutics has suspending dosing and new patient enrollment in all cohorts of the HALO trial, a study evaluating the compound HT-100 in patients with Duchenne muscular dystrophy.
The trial has been suspended, based on discussions with the US Food and Drug Administration, to allow the company time to better understand the circumstances that led to this patient’s experiences. The study was due to complete this spring.
The company stated: “We are saddened to report that one of the patients in the trial, receiving 60mcg/kg/d (the highest dose in the study), is experiencing serious, life-threatening health issues, and the company is working with the FDA to analyze the situation. We do not yet know to what extent the patient’s health issues are related to HT-100 and/or to other factors.”
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