FDA lifts clinical hold on Solid's DMD gene therapy

Solid Biosciences Inc. (NASDAQ:SLDB) said FDA lifted a clinical hold on the Phase I/II IGNITE DMD trial of microdystrophin gene transfer therapy SGT-001 to treat Duchenne muscular dystrophy (DMD). Solid plans to resume enrollment under an amended protocol "as quickly as possible."

FDA placed a full clinical hold on the trial in March after the first patient treated with SGT-001 was hospitalized due to laboratory findings of decreased platelet count followed by decreased red blood cell count, transient renal impairment and evidence of complement activation (see "FDA Places Hold on Solid's Phase I/II DMD Trials")...