An experimental drug designed to reduce scarring in Duchenne MD-affected muscles shows signs of safety and desired activity; FDA will speed its review
HT-100, an experimental drug being developed for Duchenne muscular dystrophy (DMD) with support from MDA, has shown preliminary safety and signs of the desired effects on scar tissue formation in the first 17 trial participants, and it has received "fast track" designation from the U.S. Food and Drug Administration (FDA).
A trial of an experimental compound to counteract muscle inflammation and scarring in Duchenne MD resumes, after an interruption to complete a dog safety study
Update (July 3, 2014): Akashi says the HT-100 main trial is now closed; the extension study is open to those who have already participated in the main trial.
An MDA Venture Philanthropy grant of $500,000 to Halo Therapeutics will support the development of HT-100, an experimental drug for Duchenne muscular dystrophy
Update (June 12, 2014): In a June 12, 2014, announcement, Halo Therapeutics said that it has resumed testing of HT-100, an experimental oral drug intended to reduce scar formation and inflammation and promote healthy muscle regeneration in DMD. The company will now continue to enroll and dose DMD ptients in its ongoing clinical trial and extension study.
30-person trial will test the safety, tolerability and pharmacokinetics of the experimental drug HT-100 in boys with Duchenne muscular dystrophy
Update (Jan. 6, 2014): In a Dec. 23, 2013, announcement, Halo said the U.S. Food and Drug Administration (FDA) had placed this trial on "clinical hold" because of some adverse events that occurred in dogs being treated with HT-100. No further dosing of patients will occur until this issue has been resolved.