Edgewise's Dystrophy Candidate Lowers Muscle Damage Biomarkers

Edgewise Therapeutics Inc EWTX announced 2-month interim results from the ARCH study of EDG-5506 in adults with Becker Muscular Dystrophy (BMD).
EDG-5506 was well-tolerated with no discontinuations or dose reductions. The most common adverse events observed at the 10 mg dose were dizziness (17%) and somnolence (17%). These were generally transient and typically observed in the first few days of dosing.
All patients have subsequently been dose-escalated to 15 mg daily as per protocol.
Related: Edgewise Therapeutics Shares Jump After Positive Data On Becker Muscular Dystrophy Study.
The 2-month plasma PK data for the 10 mg once-daily dose of EDG-5506 showed exposure levels that were approximately 61% of what was observed in the Phase 1b study (dosed at 20 mg once daily for two weeks).
The reduced exposure for BMD participants in the ARCH study is consistent with the lower dose of 10 mg and a shorter half-life of EDG-5506 in BMD patients, likely associated with a decreased overall muscle mass.
EDG-5506 showed a significant decrease in key biomarkers of muscle damage. Notably, creatine kinase and fast skeletal muscle troponin I were reduced by an average of 30% and 68%, respectively, after two months.
"We're encouraged by the decrease in biomarkers, particularly in the context of the increased activity observed in BMD patients treated with EDG-5506," said Joanne Donovan, Chief Medical Officer of Edgewise.
Price Action: EWTX shares closed higher by 6.08% at $6.63 on Friday.

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