US FDA lifts clinical hold on Solid Biosciences' gene therapy SGT-001
Solid Biosciences Inc (NASDAQ:SLDB) today announced that the US Food and Drug Administration has lifted its clinical hold on SGT-001, its gene therapy, which treats the degenerative disease Duchenne muscular dystrophy.
The FDA’s clinical hold on its Phase 1/2 trial for SGT-001 called IGNITE DMD was put in place last March after the first patient dosed with SGT-001 fell ill. The patient’s platelet count and red blood cell count decreased, and his renal activity was also impaired. After being treated, he made a full recovery.
Ilan Ganot, Solid’s founder and chief executive, said the resumption of the study would be immediate in the wake of the overturning of the clinical hold.
READ: Solid Biosciences plunges after FDA puts Phase 1/2 DMD trial on hold
“We are pleased to have been able to provide the FDA with a comprehensive response resulting in the removal of the clinical hold so we can continue development of this important potential treatment,” said Ganot.
As part of the lifting of the clinical hold, Solid has made changes to the study’s protocol. It’s adding IV glucocorticoids in the first weeks after the administration of SGT-001 and beefing up its monitoring system.
Solid also plans to enroll and give doses to several children before dosing additional adolescents. The company expects to report initial data from an interim analysis of IGNITE DMD in the second half of next year.
Solid shares traded 2.6% higher at US$27.18 in afternoon trade.
Story by ProactiveInvestors
Source: http://www.proactiveinvestors.com/companies/news/199076/us-fda-lifts-clinical-hold-on-solid-biosciences-gene-therapy-sgt-001-199076.html
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