Exhibit 99.1
Solid Biosciences Provides Second Quarter 2021 Business Update and Financial Results
- Clinical activities underway to advance patient dosing in IGNITE DMD; next patient dosing anticipated in Q4 2021 -
- Development activities continue for pipeline initiatives SGT-003 and Ultragenyx collaboration, next generation gene therapy programs for Duchenne patients -
- Company ends Q2 with approximately $249 million cash and investments; cash runway into Q4 2022 -
CAMBRIDGE, Mass., August 16, 2021 (GLOBE NEWSWIRE) — Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today provided a second quarter 2021 business update as well as financial results for the quarter ended June 30, 2021.
“We continue on our mission of developing meaningful treatments for patients with Duchenne,” said Ilan Ganot, Chief Executive Officer, President and Co-Founder of Solid Biosciences. “During the second quarter, we made progress on our key strategic priorities and strengthened our team. Specifically, we advanced clinical activities to prepare for the next patient to be dosed in the IGNITE DMD clinical trial of SGT-001, furthered our next generation Duchenne gene therapy program, SGT-003, and progressed our Duchenne collaboration with Ultragenyx. We also continue to maintain a strong balance sheet to support further investment into our portfolio of Duchenne programs.”
IGNITE DMD Clinical Trial Update
As previously reported, in April 2021, the eighth patient in IGNITE DMD, and fifth patient in the 2E14 vg/kg cohort, was treated with SGT-001. The patient experienced an SAE which has since fully resolved.
Following dosing of two patients with Solid’s second-generation manufacturing process and clinical strategy, Solid conducted an extensive review of all clinical data, resulting in a strengthened risk mitigation plan including new patient management guidance, which has also been submitted to the FDA. Activities are underway to advance IGNITE DMD with the next patient dosing anticipated in Q4 2021.
No new drug-related safety findings have been identified in Patients 1 through 8 in post-dosing periods of 90-days to more than 3 years. The Company continues to follow dosed patients and collect data to support the potential benefit from dosing SGT-001.
R&D Pipeline Update
Preclinical activities progressed on Solid’s internally developed next generation Duchenne microdystrophin gene transfer program, SGT-003, including proof of concept research; manufacturing, regulatory and clinical strategies; and development and validation of screening assays to support clinical dosing. The Company is targeting an IND submission for SGT-003 in early-2023.