USFDASep 24, 2026, 07:45 AM
Satellos Bioscience: FDA Clears IND for FSHD Drug; Secures $5M Financing
AI Summary
Satellos Bioscience Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for forazapadin for the treatment of facioscapulohumeral muscular dystrophy (FSHD). The company plans to initiate a Phase 2 clinical study in FSHD in the fourth quarter of 2026. Additionally, the FSHD Canada Foundation has agreed to provide up to US$5 million in non-dilutive financing toward the clinical development of forazapadin in FSHD. This funding will support a Phase 2 study evaluating forazapadin at two dose levels.
Key Highlights
- Satellos Bioscience announces FDA clearance of IND application for forazapadin in Facioscapulohumeral Muscular Dystrophy (FSHD).
- FSHD Canada Foundation to provide up to US$5 million in non-dilutive financing for clinical development.
- Phase 2 study in FSHD expected to begin in Q4 2026, evaluating forazapadin at 60 mg and 120 mg doses.
- Forazapadin targets AAK1, a protein believed to restore natural muscle repair and regeneration.
- FSHD affects an estimated 800,000 individuals worldwide with no approved disease-modifying therapies.
- Forazapadin is also being evaluated for Duchenne muscular dystrophy (DMD).
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