Solid Biosciences Says FDA Grants Fast Track Designation For Gene Therapy Candidate SGT-003
(RTTNews) - Life sciences company Solid Biosciences Inc. (SLDB) announced Thursday that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for SGT-003, the company's next-generation Duchenne muscular dystrophy gene therapy candidate.
IND clearance by the FDA for SGT-003 was received in November 2023. The planned Phase 1/2 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 DMD 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 4 to < 6 years of age with DMD. Long-term safety and efficacy will be evaluated for a total of 5 years following treatment.
Solid Biosciences Appoints Kevin Tan As New CFO
FTSE 100 Rises On Corporate Earnings; BoE Rate Decision In Focus
Yen Rises As BoJ's Tamura Signals Rate Hikes
Sensex, Nifty End Slightly Lower Before RBI Policy Outcome
CAC 40 Advances As Societe Generale, ArcelorMittal Rally On Earnings
UK Construction Sector Contracts For First Time In 11 Months
German Construction Sector Continues To Shrink
