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

Solid Biosciences Inc. (SLDB), said Thursday that the U.S. Food and Drug Administration or FDA has lifted the clinical hold placed on the company's IGNITE DMD Phase I/II clinical trial.

Solid Biosciences is a life sciences company focused on developing meaningful therapies for Duchenne muscular dystrophy (Duchenne).

In July, the FDA had requested from the company further manufacturing information, updated safety and efficacy data for all patients dosed, and also provided direction on total viral load to be administered per patient.

Solid Biosciences noted that based on its response to these requests, the FDA acknowledged that the company has 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. We are working diligently to complete all activities necessary to resume dosing, which we expect to occur in the first quarter of 2021," said Carl Morris, Chief Scientific Officer at Solid Biosciences.

Solid Biosciences noted that modifications to the IGNITE DMD trial protocol and improvements to manufacturing processes will enable continued program development.
The company will reduce 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, along with the delivery of fewer viral particles due to the manufacturing process improvements, will reduce the total viral load of patients while continuing dosing at the 2E14 vg/kg dose.

Solid Biosciences has also provided the FDA with updated safety and functional efficacy data (including 6-Minute Walk Test and North Star Ambulatory Assessment data) for all patients dosed to date in IGNITE DMD. There have been no additional drug-related adverse events up to 30 months post dosing, the company noted.

To mitigate the risk of serious drug-related adverse events, Solid Biosciences is amending the IGNITE DMD clinical protocol to include the prophylactic use of both anti-complement inhibitor eculizumab as well as C1 esterase inhibitor, while increasing the prednisone dose in the first month post dosing.

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