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.