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Dyne Therapeutics Receives FDA Clearance to Start Trial of Muscle Disease Treatment

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Dyne Therapeutics (DYN) said Tuesday the US Food and Drug Administration cleared its investigational new drug application for DYNE-302, allowing the company to begin a Phase 1 trial in patients with facioscapulohumeral muscular dystrophy.

The randomized, placebo-controlled, double-blind, multiple ascending-dose Phase 1 trial will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of DYNE-302 in ambulatory adults with FSHD, including biomarkers of DUX4 activity, the company said.

Dyne said DYNE-302 is its third clinical-stage program based on its FORCE platform and plans to pursue a traditional US approval pathway for the therapy.

Dyne Therapeutics shares were up 1% in premarket trading.

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