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Solid Biosciences Announces FDA Lifts Clinical Hold on IGNITE DMD Clinical Trial
– Modifications to IGNITE DMD trial protocol and improvements to manufacturing processes enable continued program development – CAMBRIDGE, Mass., Oct. 01,
About this update from Solid Biosciences Inc.
[{"type":"text","content":"– Modifications to IGNITE DMD trial protocol and improvements to manufacturing processes enable continued program development –\n CAMBRIDGE, Mass., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), 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.” As part of its commitment to continuously improve its manufacturing processes, Solid implemented and shared with the FDA manufacturing process changes that remove the majority of empty viral capsids, allowing target dosing to be achieved with fewer viral particles. This reduction in the total amount of virus delivered to each patient is intended to support safe dosing of SGT-001 for the duration of the IGNITE DMD trial. In its July 2020 communication, the FDA requested additional information regarding the comparability between SGT-001 made using Solid’s prior manufacturing process and its current, improved process. In response to this request, Solid submitted data from a new, quantitative, in vitro microdystrophin expression assay that demonstrates comparability between SGT-001 manufactured by the two processes. Solid is reducing the maximum weight of the next two patients dosed to 18 kg per patient, with safety outcomes from these two patients driving potential weight increase of patients dosed subsequently. This reduction, in conjunction with the delivery of fewer viral particles as a result of the Company’s manufacturing process improvements, will reduce patients’ total vira...