Business
Solid Biosciences Reports Third Quarter 2020 Financial Results and Provides Business Update
–IGNITE DMD clinical trial expected to resume dosing in the first quarter of 2021– -Collaboration with Ultragenyx creates opportunities to develop additional
About this update from Solid Biosciences Inc.
[{"type":"text","content":"–IGNITE DMD clinical trial expected to resume dosing in the first quarter of 2021–\n -Collaboration with Ultragenyx creates opportunities to develop additional gene therapies for Duchene muscular dystrophy- – Enhanced cash position resulting from Ultragenyx collaboration and fund-raising activity expected to provide financial runway into the second half of 2021 – – Conference call and webcast scheduled for 8:30 AM ET – CAMBRIDGE, Mass., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy (Duchenne), today reported financial results for the third quarter ended September 30, 2020 and provided a business update. “With the FDA’s lifting of the clinical hold on the IGNITE DMD trial, we are well underway in completing the activities necessary to resume dosing, which we expect will occur in the first quarter of 2021,” said Ilan Ganot, Chief Executive Officer, President and Co-Founder of Solid Biosciences. “This important event and establishing a strategic collaboration with Ultragenyx to develop additional gene therapies for Duchenne mark important progress toward our goal of improving the lives of patients living with Duchenne. We are also increasing production of SGT-001 using our improved manufacturing process in support of dosing additional patients in 2021. Additionally, we strengthened our balance sheet with additional capital from the Ultragenyx collaboration and our recent at-the-market, or ATM, equity financing, both of which will support our planned clinical advancement of SGT-001.” Recent Developments In October 2020, Solid announced that the U.S. Food and Drug Administration (FDA) lifted the clinical hold placed on the Company’s IGNITE DMD Phase I/II clinical trial. Solid expects to resume dosing in the clinical trial in the first quarter of 2021. Solid implemented and shared with the FDA manufacturing process changes that remove the majority of empty viral capsids. The improved process is averaging approximately 90% full capsids, allowing target dosing to be achieved with fewer viral particles.Solid submitted data from a new, quantitative, in vitro microdystrophin expression assay that demonstrates comparability between SGT-001 manufactured by the two processes.Solid is reducing the maximum weight of the n...