Tonight at PPMD’s Virtual Annual Conference, Solid Biosciences shared that their IGNITE DMD Phase I/II clinical trial will remain on clinical hold. They also issued a press release here. During this hold, Solid will continue to work with the FDA to address their requests. The safety of the Duchenne community is Solid’s top priority and PPMD appreciate Solid providing regular updates as they continue working collaboratively with the FDA to resolve the clinical hold.
We hope to host a webinar with Solid soon to learn more about this clinical hold and next steps.
Read the Announcement from Solid:
Solid Biosciences Provides Update Regarding the IGNITE DMD Phase I/II Clinical Hold
July 24, 2020 at 5:50 PM EDT
CAMBRIDGE, Mass., July 24, 2020 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, today announced that it received written communication from the U.S. Food and Drug Administration (FDA) that the Company’s IGNITE DMD Phase I/II clinical trial remains on clinical hold.
In November 2019, the FDA placed IGNITE DMD on clinical hold as the result of a serious adverse event (SAE) that occurred in the sixth patient dosed in the trial; as previously reported the SAE has fully resolved. In April 2020, Solid provided the FDA with information and measures intended to improve patient safety and in May 2020, Solid received written communication from the FDA that the trial remained on hold. In June 2020, the Company submitted a response to the FDA that provided data related to manufacturing process improvements. Today, the FDA responded by maintaining the clinical hold and requesting further manufacturing information, updated safety and efficacy data for all patients dosed, and providing direction on total viral load to be administered per patient. Solid is evaluating next steps and will provide an update as appropriate.
“Patient safety is our highest priority and we plan to continue our dialogue with the FDA to determine the appropriate path for SGT-001,” said Ilan Ganot, Co-Founder, President and Chief Executive Officer of Solid Biosciences. “We are disappointed with the outcome today, however, we will continue to work with the FDA as we believe the clinical development of SGT-001 could offer meaningful benefits to patients with this devastating disease.”