(Reuters) – Capricor Therapeutics Inc said on Wednesday it had put on hold a clinical trial of its drug to treat Duchenne muscular dystrophy (DMD), a muscle-wasting disorder, citing a safety review.
The review follows a severe allergic reaction during infusion of the drug, the company said in a filing here. The patient responded well to medical treatment and is currently asymptomatic.
The company has notified the U.S. Food and Drug Administration and is working with the agency on a mitigation plan, it said.
The trial, named “HOPE-2”, was testing the company’s lead experimental drug CAP-1002, according to California-based Capricor’s website.
DMD is a rare, genetic disorder that hampers muscle movement, mainly in men, affecting one in every 3,500 to 5,000 males. More than 90 percent of patients become wheelchair-bound by age 15.
Reporting by Manas Mishra in Bengaluru; Editing by Anil D’Silva and Shinjini Ganguli