Business
Satellos Announces IND Submission to the U.S. FDA and Global Regulatory Filings to Advance a Phase 2 Clinical Trial of SAT-3247 in Children with Duchenne Muscular Dystrophy
Regulatory submissions filed in the U.S., UK, Europe, Serbia and Australia Th...
About this update from Satellos Bioscience Inc
[{"type":"text","content":"Satellos Announces IND Submission to the U.S. FDA and Global Regulatory Filings to Advance a Phase 2 Clinical Trial of SAT-3247 in Children with Duchenne Muscular Dystrophy\n\n\n .bwlistsquare { list-style-type: square }\n \n\n\n\n\n\n\n Regulatory submissions filed in the U.S., UK, Europe, Serbia and Australia\n \n\n\n\n\n\n\n\n\n\n Three-month randomized placebo-controlled study to assess safety, pharmacokinetics, dose, muscle biopsies, and measures of function in ambulatory children\n \n\n\n\n\n\n\n\n\n\n First patient expected to be enrolled into the study by the end of 2025\n \n\n\n\n\n\n\n\n\n\n Long-term extension study approved in Australia with adult patients from the Phase 1b trial; additional adult patients also planned\n \n\n\n\n\n\n\n\n\n\n Company also provides financial update with 1.7 million warrants exercised, resulting in gross proceeds of Cdn$1.0 million in Q3 2025\n \n\n\n\n\n\n\n Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) (“Satellos” or the “Company”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), along with parallel regulatory filings in the United Kingdom, Europe, Serbia and Australia, to initiate a Phase 2 clinical trial of SAT-3247 in ambulatory children with Duchenne muscular dystrophy (Duchenne or DMD).\n \n\n The planned Phase 2 trial will enroll children with Duchenne in the U.S., following FDA approval, and globally, following country health authority approvals. The three-month randomized, placebo-controlled study will assess safety and tolerability as well as key measures of strength, function, biomarkers, and muscle health. A nine-month open-label extension for this study is also being planned.\n \n\n “Filing our Phase 2 clinical trial submissions in the US and globally marks a major milestone for Satellos in advancing SAT-3247’s potential to treat Duchenne in a novel way,” said Satellos Co-Founder and CEO Frank Gleeson. “Current therapies do not address the fundamental challenge in Duchenne, which we have identified — the body’s impaired muscle-repair process. With SAT-3247, our goal is to re-boot that regenerative cycle with ...