Solid Biosciences Inc 8-K/A, filed Sep 27, 2021
Solid Biosciences Inc. (SLDB)
About this 8-K/A
Solid Biosciences Inc filed this 8-K/A on September 27, 2021, reporting on events of September 23, 2021.
Items reported
- Item 8.01: Other events
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Item 8.01. Other Events.
FVC Functional Data
The FVC for patients four through six continued to show stability or improvement 1.5 years following SGT-001 administration, while natural history analyses suggest that similarly aged patients to those enrolled in IGNITE DMD would normally be expected to exhibit a decline of 7.5% over the same time period. The mean improvement in percent predicted FVC from baseline to 1.5 years for patients four through six was 8.5% (Range: +0.6% to +22.5%), and the mean difference compared with natural history data was +16.0% over the same time period.
The following table summarizes the 1 year and 1.5 year FVC functional data of IGNITE DMD for patients treated with the high dose 2E14 vg/kg of SGT-001:
Summary of FVC Interim Functional Data of IGNITE DMD
Absolute Change From Baseline to 1 Year and 1.5 Years
| Baseline | 1 yr | 1.5 yrs |
FVC% 1 yr Change from Baseline |
FVC% 1.5 yr Change from Baseline |
||||||||||||||||||
| Patient Age at Baseline |
Patient 4 10.7 years |
93.7 | 96.8 | 94.3 | +3.1 | % | +0.6 | % | ||||||||||||||
| Patient 5 6.8 years |
73.4 | 110.1 | 95.9 | +36.7 | % | +22.5 | % | |||||||||||||||
| Patient 6 7.7 years |
104.2 | 111.5 | 106.7 | +7.3 | % | 2.5 | % | |||||||||||||||
| Mean Change |
Patients 4-6 | +15.7 | % | +8.5 | % | |||||||||||||||||
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 27, 2021 | By: | /s/ Ilan Ganot | ||||
| Name: Ilan Ganot Title: Chief Executive Officer | ||||||