other material
confidence high
sentiment positive
materiality 0.75
Edgewise reports positive Phase 1 MAD results for EDG-5506; Phase 2 in BMD and DMD planned for 2022
Edgewise Therapeutics, Inc.
- EDG-5506 generally well tolerated; no serious adverse events; mild dizziness/somnolence resolved.
- PK data showed muscle concentrations well above efficacious levels from preclinical DMD models.
- PD demonstrated dose-proportional inhibition of involuntary twitch without affecting voluntary strength or cardiac myosin.
- Phase 1b dosing of BMD patients initiated; Phase 2 in BMD expected Q1 2022, DMD H2 2022.
- Follow-on open-label study in BMD planned for Q1 2022 to assess biomarkers over 3 months.