TORONTO, Canada — 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).
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.
“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 the potential to restore muscle, improve functional outcomes and truly change lives.”
SAT-3247 is an oral small-molecule therapy designed to restore the body’s ability to regenerate muscle, a process that is impaired in Duchenne. In a recently completed Phase 1b study in five adults with Duchenne, SAT-3247 was safe and well tolerated and the pharmacokinetics of SAT-3247 in adults with Duchenne mirrored that of healthy volunteers. Importantly, efficacy was explored, and an approximate doubling of grip strength was observed over 28 days along with a 5% improvement in force vital capacity (lung function). Satellos has initiated an 11-month extension study in Australia to evaluate long-term safety and efficacy among individuals who participated in the Phase 1b trial. Further expansions of this trial are planned.
CORPORATE UPDATE
Satellos is also pleased to announce that since its last reporting period, it has received investor support through the exercise of 1,737,500 share purchase warrants (“Warrants”) for gross proceeds of C$1,042,500. The Warrants were issued pursuant to a financing that closed on Sept. 13, 2022, pursuant to which an aggregate of 4,375,000 Warrants were issued. As disclosed in Satellos’ Q2 2025 financial statements, a total of 911,000 Warrants had been previously exercised. The remaining 1,726,500 Warrants expired as of Sept. 13, 2025, pursuant to the expiry date.
ABOUT SAT-3247
SAT-3247 is a proprietary, oral, small molecule drug being developed by Satellos as a novel treatment to regenerate skeletal muscle that is lost in Duchenne muscular dystrophy and other degenerative or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD, independent of dystrophin and regardless of exon mutation status.
ABOUT SATELLOS BIOSCIENCE INC.
Satellos is a clinical-stage drug development company focused on restoring natural muscle repair and regeneration in degenerative muscle diseases. Through its research, Satellos has developed SAT-3247, a first-of-its-kind, orally administered small molecule drug designed to address deficits in muscle repair and regeneration. SAT-3247 targets AAK1, a key protein that Satellos has identified as capable of replacing the signal normally provided by dystrophin in muscle stem cells to effect repair and regeneration. By restoring this missing dystrophin signal in DMD, SAT-3247 enables muscle stem cells to divide properly and more efficiently, promoting natural muscle repair and regeneration. SAT-3247 is currently in clinical development as a potential disease-modifying treatment initially for DMD. Satellos also is leveraging its proprietary discovery platform MyoReGenX™ to identify additional muscle diseases or injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and represent future clinical development opportunities. For more information, visit www.satellos.com.
Satellos Contacts
Investors Liz Williams, CFO, [email protected]
Media Emily Williams, Senior Director of Communications, [email protected]
Clinical Trial Info [email protected]