Solid Biosciences Announces Clinical Hold On SGT-001 Phase I/II Clinical Trial For Duchenne

Solid Biosciences announced that the FDA has placed their 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 is home with his family with no symptoms. 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. PPMD is hopeful that the individual will remain stable and that this incident will be resolved so that studies can continue.

To read the full press release, click here.

Read Solid's letter to the community below.

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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