FDA maintains clinical hold on Solid Bio’s Ignite DMD trial

The FDA notifies Solid Biosciences (NASDAQ:SLDB) that its IGNITE DMD Phase I/II clinical trial remains on clinical hold.

In November 2019, the Agency placed IGNITE DMD on clinical hold as the result of a serious adverse event related to the study drug. The study evaluated gene therapy candidate SGT-001 in Duchenne muscular dystrophy.

Thereafter, the company provided measures taken to improve patient safety, as well as information related to improvements to its manufacturing process.

On Friday, July 24, the FDA responded by maintaining the clinical hold and requesting further manufacturing information, updated safety and efficacy data for all patients dosed, and providing direction on total viral load to be administered per patient.

https://seekingalpha.com/news/3595062-fda-maintains-clinical-hold-on-solid-bios-ignite-dmd-trial