Satellos Bioscience Switches BASECAMP Phase 2 Primary Endpoint To MRI Fat Fraction Following FDA Feedback
Benzinga Newsdesk 4 hours ago
News
Fat fraction, together with clinical endpoints, may support a potential accelerated approval pathway for forazapadinProtocol amendment submitted to implement the new primary efficacy endpointTopline 12-week
- 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.
