Solid Biosciences (Nasdaq: SLDB) is back on track in its mission to deliver a gene therapy that dramatically changes the course of Duchenne muscular dystrophy (DMD).
The US Food and Drug Administration (FDA) has lifted the clinical hold on the IGNITE DMD study, the US biotech’s Phase I/II clinical trial for its investigational microdystrophin gene transfer, SGT-001.
A clinical hold was placed on the trial following a report of a serious adverse event in the first patient dosed with SGT-001. The event was characterized by a decrease in platelet count followed by a reduction in red blood cell count, transient renal impairment and evidence of complement activation.
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