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Satellos Receives Clearance by U.S. FDA and Global Regulators to Initiate Pediatric Phase 2 Study of SAT-3247 for Duchenne Muscular Dystrophy
- Placebo-controlled Phase 2 study will evaluate SAT-3247 treatment over three months among amb...
About this update from Satellos Bioscience Inc
[{"type":"text","content":"Satellos Receives Clearance by U.S. FDA and Global Regulators to Initiate Pediatric Phase 2 Study of SAT-3247 for Duchenne Muscular Dystrophy\n\n\n\n\n\n\n -\n \n Placebo-controlled Phase 2 study will evaluate SAT-3247 treatment over three months among ambulatory children with Duchenne\n \n\n -\n \n Study endpoints include safety and tolerability, effect on muscle force and function, and impact on muscle quality and regeneration\n \n\n -\n \n Enrollment of first study participant anticipated by end of 2025\n \n\n\n\n\n\n Satellos Bioscience Inc\n \n . (TSX: MSCL, OTCQB: MSCLF) (“Satellos” or the “Company”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced that it has received Investigational New Drug (IND) clearance by the U.S. Food and Drug Administration (FDA), as well as other global regulatory agencies, to conduct SAT-3247-CL-201, a three-month, randomized, double-blind, placebo-controlled, proof-of-concept, Phase 2 study of SAT-3247 in 51 ambulatory children with Duchenne muscular dystrophy (Duchenne or DMD).\n \n\n “We are delighted to achieve U.S. and global clearance to start our Phase 2 pediatric study of SAT-3247, which we have named BASECAMP. This important milestone positions Satellos to demonstrate the potential for SAT-3247 to safely restore the body’s ability to repair and regenerate muscle in children living with Duchenne, and to alter disease progression,” said Frank Gleeson, co-founder and CEO of Satellos. “With encouraging functional data from our Phase 1b study in adults, we have confidence in the potential for SAT-3247 to make an impact for children with Duchenne, and we are excited to begin enrollment in the trial imminently.”\n \n\n In addition to the FDA clearance, the United Kingdom’s Medicine and Healthcare products Regulatory Agency (MHRA) granted authorization of the company’s Clinical Trial Application (CTA); Australia’s Human Research Ethics Committee (HREC) accepted the Therapeutic Goods Administration’s (TGA’s) Clinical Trial Notification (CTN) scheme for regulatory authorization; and the Medicines and Medical Devices Agency of Serbia (ALIMS) approved the company’s CTA. The clinical trial application is still under...