Solid Biosciences Inc.
1707502
Nov 15, 2023, 12:59 PM
0001193125-23-277552
Items (3)
Item 7.01. Regulation FD Disclosure. On November 14, 2023, Solid Biosciences Inc. (the “ Company”) issued a press release announcing that it received U. S. Food and Drug Administration (“ FDA”) clearance of an Investigational New Drug application (“ IND”) for SGT-003, the Company’s next-generation Duchenne Muscular Dystrophy (“ Duchenne”) gene therapy candidate. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form8-Kand is incorporated herein by reference. The information provided under Item 7.01 of this Current Report on Form 8-K (includingExhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “ Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events. On November 14, 2023, the Company announced that it received FDA clearance of an IND for SGT-003. The Company plans to move expeditiously to submit the planned Phase 1/2 clinical trial for institutional review board approval at the clinical trial sites and expects to commence patient screening shortly thereafter. The planned Phase 1/2 clinical trial, SGT-003-101, is a first in human, open-label, multicenter trial to determine the safety and tolerability ofSGT-003in pediatric patients with Duchenne at a dose of 1E14vg/kg. SGT-003will be administered as a one-timeintravenous infusion to patients in two cohorts with a minimum of three patients each, with the potential for cohort expansion. Cohort 1 will study patients aged four to less than 6 years of age with Duchenne. The Company plans to evaluate long-term safety and efficacy for a total of five years following treatment.
Item 9.01. Financial Statements and Exhibits. (d) Exhibits: 99.1 Press Release dated November 14, 2023 ─────────────────────────────────────────────────── 104 Cover Page Interactive Data File (formatted as Inline XBRL)