CAMBRIDGE, MASS, April 18, 2018
Dear Duchenne Community Members,
As valued partners in the fight against Duchenne muscular dystrophy (DMD), we wanted to share with you an update on our ongoing interactions with the U.S. Food and Drug Administration (FDA) on IGNITE DMD, our Phase I/II clinical trial to assess the safety and efficacy of SGT-001 in patients with DMD. We also shared this update in a press release that can be found here.
As you know, we recently announced that the FDA put IGNITE DMD on full clinical hold due to a serious adverse event (SAE) experienced by the first patient dosed with SGT-001. We reported the event to the FDA and have recently received the formal clinical hold letter, which outlined the agency’s additional information requests. We are working tirelessly to develop a comprehensive plan to address these questions and are committed to maintaining dialogue with the FDA with the hope of resuming IGNITE DMD as soon as possible. Most importantly, we’re pleased to say the treating physician has reported the patient is doing well.
As part of our update, we are also happy to share that we have been able to successfully resolve the previously-announced partial clinical hold on the planned high dose of SGT-001 in IGNITE DMD, which was due to manufacturing-related questions from the FDA. While encouraging, IGNITE DMD remains on hold until we address the full clinical hold as mentioned above.
Solid is deeply committed to advancing our mission to solve DMD. Our goal is and always has been to bring forward only the programs that we believe have life-changing potential and develop a portfolio of treatments to benefit all patients, regardless of their underlying genetic mutation, age or stage of disease. We knew this wasn’t going to be easy, but our mission and the possibility of helping those affected by this cruel disease guide every decision we make and project we take on.
We appreciate the Duchenne community’s continued support. We will provide additional updates in the future.
The Solid Team