UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01. | Other Events. |
On September 29, 2021, Solid Biosciences Inc. (the “Company”) issued a press release reporting additional pulmonary function data from the first six patients in the Company’s ongoing IGNITE DMD Phase I/II clinical trial of SGT-001. The data will be presented in a poster session at the Child Neurology Society 50th Annual Meeting.
The pulmonary function results include percent predicted peak expiratory flow (“PEF % predicted”) and forced expiratory volume in one second (“FEV1 % predicted”) one year post SGT-001 administration. The data were collected from the first six patients dosed in IGNITE DMD (three at the low dose of 5E13 vg/kg and three at the high dose of 2E14 vg/kg) and three untreated control patients. Certain patients were not evaluable due to either missed patient assessments or not meeting the clinically acceptable criteria for the respective assessment.
Four of these six patients dosed with SGT-001 and two of three patients in the untreated control cohort were evaluable for PEF % predicted assessment, with improvements noted in all dosed patients and declines noted in the untreated control patients. Patients in the low-dose cohort, Patients 1 and 3, demonstrated improvements in PEF % predicted from baseline to 1 year of +2.5% and +38.5%, respectively, and patients in the high-dose cohort, Patients 4 and 6, demonstrated improvements of +15.9% and +26.7%, respectively, at one year. Patients in the untreated control cohort, Control Patients 1 and 3, had declines of -1.1% and -18.2%, respectively, at one year.
Five of these six patients dosed with SGT-001 and all three patients in the untreated control cohort were evaluable for FEV1 % predicted assessment, with improvements noted in all dosed patients and declines noted in the untreated control patients. Patients in the low-dose cohort, Patients 1 and 3, demonstrated improvements in FEV1 % predicted from baseline to 1 year of +13.4% and +4.3%, respectively, and patients in the high-dose cohort, Patients 4 - 6, demonstrated improvements of +10.8%, +15.5% and +2.8%, respectively, at one year. Patients in the untreated control cohort, Control Patients 1 - 3, reported declines of -8.7%, -17.0% and -12.0%, respectively, at one year.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| SOLID BIOSCIENCES INC. | ||||||
| Date: September 29, 2021 | By: | /s/ Ilan Ganot | ||||
| Name: | Ilan Ganot | |||||
| Title: | Chief Executive Officer | |||||