Satellos Changes Primary Efficacy Endpoint in BASECAMP Phase 2 Pediatric Trial to MRI-Measured Fat Fraction Following FDA Feedback
Key Highlights
- ➤Satellos replaces dynamometry with MRI-measured vastus lateralis fat fraction as BASECAMP’s primary endpoint
- ➤BASECAMP topline 12-week placebo-controlled data expected in Q1 2027
- ➤Forazapadin may support an accelerated approval pathway if BASECAMP results are supportive
- ➤TRAILHEAD showed 3.7 percentage-point reduction in biceps brachii fat fraction by Day 140
Expert Statements
Frank Gleeson, Co-founder and Chief Executive Officer of Satellos
“Our goal is clear: if BASECAMP delivers supportive results, we intend to move rapidly toward a potential accelerated approval pathway for forazapadin”
Frank Gleeson, Co-founder and Chief Executive Officer of Satellos
“We are delighted with our recent interactions with the FDA which have helped sharpen our clinical and regulatory strategy and given us greater clarity on the evidence that could support a path to accelerated approval. With the BASECAMP readout approaching, our focus is on rigorous execution, continued engagement with the FDA and moving with urgency toward our ultimate goal of bringing forazapadin to patients living with Duchenne.”
Wildon Farwell, M.D., Chief Medical Officer of Satellos
“We believe that change in MRI-measured muscle fat fraction of the vastus lateralis has the potential to serve as a surrogate endpoint reasonably likely to predict clinical benefit from forazapadin during BASECAMP’s 12-week placebo-controlled period and randomized active treatment period”
Wildon Farwell, M.D., Chief Medical Officer of Satellos
“It is an objective measure of muscle composition that has been associated with disease progression and loss of ambulation in boys living with Duchenne. Importantly, we have also observed encouraging clinical evidence on this measure in TRAILHEAD, where adults treated with forazapadin demonstrated an improvement in muscle fat fraction of the biceps brachii over five months. Together, these data give us increased confidence in muscle fat fraction as a measure of forazapadin’s biological activity in BASECAMP and as a proposed surrogate endpoint to support a potential accelerated approval pathway.”
* Fat fraction, together with clinical endpoints, may support a potential accelerated approval pathway for forazapadin * Protocol amendment submitted to implement the new primary efficacy endpoint * Topline 12-week placebo-controlled BASECAMP data expected in Q1 2027 * Conference call and webcast today at 8:00 a.m. ET TORONTO, Nov. 06, 2026 (GLOBE NEWSWIRE) -- Satellos Bioscience Inc. (NASDAQ: MSLE, TSX: MSCL), a clinical-stage biotechnology company developing potentially life-improving medicines to treat degenerative muscle disorders, today announced that, following feedback from the U.S. Food and Drug Administration (FDA), it has selected change in vastus lateralis fat fraction measured by magnetic resonance imaging (MRI) as the primary efficacy endpoint in the BASECAMP Phase 2 clinical study in boys ages 7, 8 or 9 with Duchenne muscular dystrophy (DMD). Change in MRI-measured fat fraction will replace dynamometry as the study’s primary efficacy endpoint. Forazapadin is an investigational oral, small molecule designed to enhance the body’s natural ability to repair and regenerate muscle. Early clinical data in DMD have demonstrated a favorable safety and tolerability profile and encouraging signs of biological and functional activity.
Get started
Create a free account to read the full story.