Satellos stock jumps after FDA clears FSHD trial for forazapadin

Investing.com -- Satellos Bioscience Inc (NASDAQ:MSLE) shares rose 6.8% in premarket trading Thursday after the company announced the U.S. Food and Drug Administration cleared its Investigational New Drug application for forazapadin to treat facioscapulohumeral muscular dystrophy (FSHD).

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The FDA clearance expands development of forazapadin into a second degenerative muscle disease. Satellos plans to initiate a Phase 2 clinical study in FSHD in the fourth quarter of 2026.

The company also announced that the FSHD Canada Foundation agreed to provide up to $5 million in non-dilutive financing toward the clinical development of forazapadin in FSHD. Under the agreement, the Foundation will contribute milestone payments over the next five quarters in exchange for a capped revenue-sharing interest in future FSHD-related proceeds.

The Phase 2 study will be a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, pharmacokinetics and potential efficacy of orally administered forazapadin at 60 mg and 120 mg doses in adults aged 18 and older living with FSHD.

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FSHD is one of the most common forms of muscular dystrophy, affecting an estimated 800,000 individuals worldwide. The disease is caused by abnormal activation of the DUX4 gene, which damages muscle and contributes to progressive muscle weakness. There are currently no approved disease-modifying therapies for FSHD.

This marks the second clinical indication for forazapadin. The drug candidate is currently being evaluated for Duchenne muscular dystrophy in an ongoing Phase 2 clinical trial. Preliminary data from that trial in adults showed a favorable safety profile, reduced muscle fat fraction as measured by MRI, and increased total effort after six months of treatment at 60 mg.

Forazapadin is an oral, small molecule drug candidate that targets AAK1, a protein that Satellos believes can help restore the body's natural muscle repair and regeneration biology.

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Original Article

Satellos stock jumps after FDA clears FSHD trial for forazapadin

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