California-based drugmaker Capricor Therapeutics Inc. voluntarily halted testing of its Duchenne muscular dystrophy treatment after a patient had a severe allergic reaction during the trial.
Duchenne muscular dystrophy is a genetic disorder characterized by progressive muscle degeneration and weakness that could lead to death.
Capricor said the patient responded well to medical treatment and is now showing no symptoms.
The trial, dubbed Hope-2, was evaluating Capricor's experimental drug CAP-1002 in young men and boys. The treatment received the U.S. Food and Drug Administration's regenerative medicine advanced therapy designation in February and has also received the FDA's orphan drug and rare pediatric disease designations in the past.
Capricor notified the FDA of the issue and is working with the regulator on a mitigation plan.