This morning, Solid Biosciences issued a press release following receipt of written communication from the FDA regarding the clinical hold placed on our IGNITE DMD Phase I/II clinical trial.
The IGNITE DMD clinical trial will remain on clinical hold as Solid Biosciences will continue to work with the FDA to provide further data and analyses relating to their manufacturing process, as requested. They say to share the FDA’s commitment to patient safety and look forward to continue working collaboratively with the Agency with the goal of resolving the clinical hold.
Dear Duchenne Community,
Since day one, we have been focused on working to develop meaningful therapies for patients with Duchenne muscular dystrophy. This cause is deeply embedded into every fiber of Solid Biosciences, which was founded by individuals impacted by Duchenne. Our commitment remains unwavering.
As you may recall, the Food and Drug Administration (FDA) placed a hold on our IGNITE DMD Phase I/II clinical trial in November 2019, following a serious adverse event (SAE) in the last patient dosed. As we announced in December, the child fully recovered, and all clinical study patients continue to be monitored.
In April 2020, Solid submitted a response to the FDA that included changes to the clinical protocol designed to enhance patient safety, as well as information related to improvements to our manufacturing process. The FDA has responded by maintaining the clinical hold and requesting further data and analyses relating to this manufacturing process. We are in the process of generating these data and expect to submit this information to the FDA before the end of the third quarter of 2020.
We share the FDA’s commitment to patient safety and are working collaboratively with the agency to resolve the clinical hold. We consider patient safety our utmost priority. We believe the clinical development of SGT-001 could offer meaningful benefits to patients with this devastating disease.
We want to thank all patients and families who commit to participate in clinical trials and recognize the decision to do so is not made lightly. As always, we are grateful for your trust and support in our mission to advance meaningful therapies for the community that we serve. We are looking forward to providing you with further updates in the near future.
Your Solid Biosciences Team