Solid Bio down on another clinical hold on Duchenne gene therapy

Solid Biosciences (NASDAQ:SLDB) reports that the FDA has placed its Phase 1/2 clinical trial, IGNITE DMD, evaluating lead gene therapy candidate SGT-001 in Duchenne muscular dystrophy (DMD) patients on clinical hold after a participant experienced a serious adverse event related to the study drug.

The patient, in the second cohort that received a higher dose, experienced complement activation, thrombocytopenia, a decrease in red blood cell count, acute kidney injury and cardio-pulmonary insufficiency. No cytokine- or coagulopathy-related abnormalities were observed. The company says the individual is recovering and is being closely watched by his healthcare team.

A clinical hold stops recruitment and suspends treatment for patients already enrolled.

This is the second clinical hold placed on the study. The first occurred in March 2018 after a participant was hospitalized for decreased platelet count followed by a reduction in red blood cell count and evidence of complement activation.

Shares down 59% premarket on light volume (so far).

DMD-related tickers: SRPT, CAPR, CATB, PFE, WVE

https://seekingalpha.com/news/3517892-solid-bio-59-percent-premarket-another-clinical-hold-dmd-gene-therapy