TORONTO, Canada — Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL)(“ Satellos ” or the “ Company ”), a clinical-stage biotechnology company developing life-improving medicines to treat degenerative muscle diseases, today announced interim clinical and biomarker data for SAT-3247 at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida.
“We are excited by the clinical progress of SAT-3247 and honored to be making two oral and three poster presentations at this year’s MDA conference,” said Frank Gleeson, Satellos co-founder and CEO. “Seeing continued improvements in handgrip strength and the addition of new muscle measurements by dynamometry is both positive and encouraging. We look forward to continuing to advance SAT-3247 in 2026 for the potential benefit of people living with Duchenne and FSHD.”
The data include interim observations from the ongoing Phase 2 TRAILHEAD study in adults with DMD serum proteomic analysis from the previously completed 28-day, CL-101 Phase 1a/b trial, and the development of a novel muscle regeneration assessment tool. The Company also presented preclinical findings demonstrating enhanced muscle strength in a mouse model of FSHD.
LT-001 TRAILHEAD Study
Interim observations from the ongoing Phase 2 TRAILHEAD study include:
- Continued increase in handgrip strength compared to CL-101 baseline
- Overall stability in elbow and shoulder strength at Day 56 following re-enrollment
- Greater improvement in strength observed among participants with greater baseline muscle mass
- Additional clinical outcome assessments ongoing
CL-101 Phase 1a/b Biomarker Analysis
A serum proteomic analysis of more than 11,000 proteins from the DMD cohort in the completed, 28-day Phase 1a/b study demonstrated consistent biomarker changes following two weeks of SAT-3247 administration. Key findings include:
- Reductions observed in established DMD biomarkers such as AK1, CA3, ENO3, MB and ANKRD2
- Biomarker changes observed across all participants evaluated
- Comparable magnitude of change across participants
Regeneration Index Research
In addition to the oral presentations at MDA, Satellos also presented a poster detailing the development of a novel regenerative index (RI) based on established biomarkers that can be used to assess muscle regeneration. The RI assessment tool is being utilized in the BASECAMP study clinical protocol.
FSHD Data
The Company also presented new preclinical data evaluating SAT-3247 in a mouse FSHD model that demonstrated:
- Significant enhancement of muscle strength across a 12-week dosing period
- Findings supporting the potential applicability of SAT-3247 beyond DMD
“We are particularly interested in the data demonstrating that participants with greater baseline muscle mass are demonstrating greater improvements in strength, further supporting our strategy of evaluating SAT-3247 earlier in disease progression in the ongoing BASECAMP clinical study in a pediatric population,” said Wildon Farwell, M.D., Satellos CMO.
A copy of the presentations will be available after the session on the Events & Presentations page located at: https://ir.satellos.com/events-and-presentations/default.aspx.
ABOUT SAT-3247
SAT-3247 is a proprietary, oral, small molecule drug candidate being developed by Satellos as a novel approach to regenerating skeletal muscle lost in Duchenne muscular dystrophy (DMD) and other degenerative muscle diseases or injury conditions. Satellos is advancing SAT-3247 as a potential treatment for DMD that is independent of dystrophin and applicable regardless of exon mutation status, with ongoing Phase 2 clinical studies, including TRAILHEAD, an open-label study in adult participants, and BASECAMP, a global, randomized, placebo-controlled study in pediatric participants.
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 helping restore muscle stem-cell signaling, a process that is disrupted in DMD. By addressing the loss of dystrophin-dependent cues, SAT-3247 may re-establish the signals that support effective muscle regeneration. SAT-3247 is currently in clinical development as a potential disease-modifying treatment, initially for DMD. Satellos is also working 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.
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