- Edgewise Therapeutics Inc (NASDAQ: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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