March 14, 2018
Cambridge, MA

Letter to the Duchenne Community About the Status of the IGNITE DMD Clinical Trial

Dear Duchenne community members,

Today we announced that the U.S. Food and Drug Administration has placed our Phase I/II clinical trial for SGT-001, IGNITE DMD, on Clinical Hold following a serious adverse event that occurred in the first patient dosed, a non-ambulatory adolescent. The patient was admitted to the hospital, received treatment and, as of the writing of this letter, is home with his family with no symptoms. Details about the event can be found in the press release we issued today, which is available here. The team at Solid will be working with the principal investigator and FDA to fully understand the cause and nature of this event, as well as identify appropriate next steps as soon as possible.

Since our inception, we have been focused on working to bring meaningful treatments to patients with Duchenne muscular dystrophy (DMD). This cause is deeply personal to our company, which was founded and is led by individuals touched by DMD, and we are committed to identifying and bringing medicines to patients safely and responsibly. These principles underlie everything we do as an organization, and we take them seriously.

We greatly appreciate the trust placed in us by patients and families and will honor that through our dedication and work to end this disease. We appreciate your patience while we work to resolve this situation.

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We’re pleased to share with you that the FDA has lifted the clinical hold on IGNITE DMD.

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The Duchenne Research Fund (DRF) provided Solid with a research grant of $600,000 to support its LTBP4 program to combat fibrosis and to support novel biomarker work in Duchenne muscular dystrophy (DMD).

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It has been an exciting and emotional time for our Duchenne muscular dystrophy (DMD) community.

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