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 Form 8-K and is incorporated herein by reference.
The information provided under Item 7.01 of this Current Report on Form 8-K (including Exhibit 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.
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 of SGT-003 in pediatric patients with Duchenne at a dose of 1E14vg/kg. SGT-003 will be administered as a one-time intravenous 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. |
104 |
Cover Page Interactive Data File (formatted as Inline XBRL) |
Forward-Looking Statements
This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s SGT-003 program, including its plans to expeditiously submit the planned Phase 1/2 clinical trial for institutional review board approval at the clinical trial sites and to commence patient screening shortly thereafter, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “working” and similar expressions. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the ability to recognize the anticipated benefits of the Company’s acquisition of AavantiBio; the Company’s ability to advance SGT-003, SGT-501, AVB-401, AVB-202-TT and other preclinical programs and capsid libraries on the timelines expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities; replicate in clinical trials positive results found in preclinical studies of the Company’s product candidates; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop Duchenne and other neuromuscular and cardiac treatments and gene therapies; manage expenses; and raise the substantial additional capital needed, on the timeline necessary, to continue development of SGT-003, SGT-501, AVB-401, AVB-202-TT and other candidates, achieve its other