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Solid Biosciences Announces FDA Lifts Clinical Hold on IGNITE DMD Clinical Trial


Solid Biosciences Inc., a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the Company’s IGNITE DMD Phase I/II clinical trial. As announced in July 2020, the FDA had requested further manufacturing information, updated safety and efficacy data for all patients dosed, and provided direction on total viral load to be administered per patient. Based on the Company’s response to these requests, the FDA acknowledged that the Company satisfactorily addressed all clinical hold questions.

“We are pleased that our team was able to address the FDA’s clinical hold questions, allowing us to restart the trial,” said Carl Morris, PhD, Chief Scientific Officer at Solid Biosciences. “We are working diligently to complete all activities necessary to resume dosing, which we expect to occur in the first quarter of 2021.”

 

Solid Biosciences Announces FDA Lifts Clinical Hold On IGNITE DMD Clinical Trial