Satellos amends BASECAMP endpoint for forazapadin in DMD; FSHD trial cleared by FDA and Health Canada
The company says Phase 2 DMD topline data are expected in Q1 2027, with FSHD enrolment in the TRAVERSE study also due to begin that quarter.
Satellos Bioscience reported third-quarter 2026 results on 12 November alongside clinical updates for forazapadin, its oral AAK1 inhibitor in development for Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).
Following interactions with the US Food and Drug Administration, the company amended the protocol for its Phase 2 BASECAMP study in DMD. The primary endpoint is now fat fraction in the vastus lateralis muscle, measured by MRI. Topline data from BASECAMP are expected in the first quarter of 2027.
In FSHD, both the FDA and Health Canada have cleared the respective regulatory applications: the FDA the investigational new drug (IND) application and Health Canada the clinical trial application (CTA). Satellos expects enrolment in the Phase 2 TRAVERSE study to start in the first quarter of 2027.
On the financial side, the company reported cash of $53.0 million and a net loss of $11.2 million for the third quarter.
Why it matters
- The primary endpoint of BASECAMP has changed to an MRI-measured muscle fat fraction following FDA interactions, a point to note for teams tracking endpoint acceptability in neuromuscular disease trials.
- Parallel clearances from the FDA and Health Canada allow the FSHD programme to move forward in both jurisdictions, with TRAVERSE enrolment expected in Q1 2027.
- Both the BASECAMP topline readout and the TRAVERSE start fall in the same quarter, making Q1 2027 a key period for the forazapadin programme.
Company's press release (SEC filing): Satellos Bioscience Inc. ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.
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