Shares of Edgewise Therapeutics, Inc. (EWTX) are gaining over 11% on Monday after a clinical-stage biopharmaceutical company announced positive 4-month interim results from the ARCH open label study of EDG-5506 in adults with Becker Muscular Dystrophy.
EWTX is currently trading at $13.87, up $1.45 or 11.67%, on the Nasdaq. The stock opened its trading at $13.50 after closing Friday’s trading at $12.42. The stock has traded between $5.41 and $22.98 in the past 52-week period.
Edgewise Therapeutics announced positive 4-month interim results from the ongoing ARCH study, an open label, single-center study assessing the safety, tolerability, impact on muscle damage biomarkers, and pharmacokinetics (PK) of EDG-5506 in adults with BMD. EDG-5506 is an investigational orally administered small molecule myosin modulator designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies such as Duchenne muscular dystrophy (DMD) and BMD.
The twelve adults with BMD enrolled in the ARCH study were dose escalated to daily 15 mg oral doses of EDG-5506 at night after having initially received a 10 mg dose during the first 2 months of the study. Plasma PK at 4 months reached the target exposures observed in the Phase 1b study where BMD participants were dosed with 20 mg EDG-5506 once-daily for two weeks. EDG-5506 was well-tolerated in all participants with no discontinuations or dose reductions. The most common adverse events observed to date were dizziness, drowsiness, and headache. All eligible patients have subsequently been dose escalated to 20 mg daily as per protocol.
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