Solid Biosciences (NASDAQ:SLDB) slips 1% premarket on light volume on the heels of its update on its Phase 1/2 clinical trial evaluating Duchenne muscular dystrophy (DMD) gene transfer candidate SGT-001.
The serious adverse event in the third patient treated in the 2E14 vg/kg dose arm has fully resolved and he has resumed normal activities, although the FDA’s clinical hold is still in effect (the second such action on the study).
The company says biomarket data on two subjects show “evidence” that SGT-001 “has the potential” to deliver therapeutic benefit.
Six patients have been dosed thus far. Three-month muscle biopsies from subjects #4 and #5 in the 2E14 vg/kg arm showed that 10-20% of microdystrophin-positive muscle fibers expressed SGT-001 microdystrophin in #4 and 50-70% in #5.
Management will host a conference call this morning at 8:30 am ET to discuss the data.
Update: Shares now up 18% premarket on robust volume in apparent reaction to the resolution of the adverse event.
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