Edgewise Therapeutics has 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 Becker muscular dystrophy.
Highlights of the study:
- Remarkable North Star Ambulatory Assessment scale (NSAA) improvements relative to BMD natural
- history trajectories
- Significant decrease in levels of serum creatine kinase (CK) and fast skeletal muscle troponin I (TNNI2),
- enzyme biomarkers strongly associated with muscle damage caused by BMD –
- EDG-5506 continues to be well-tolerated, with no serious adverse events observed
The Company believes the 4-month ARCH study data with EDG-5506 provide further support that reducing contraction-induced damage in dystrophic muscle has the potential to preserve and improve muscle function while preventing disease progression in dystrophinopathies.
“Those with BMD have no approved options to treat their condition. We continue to be encouraged by EDG-5506’s safety profile and these interim 4-month data allow us to make some critical decisions on how to potentially accelerate our clinical programs in BMD and DMD.”
Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Edgewise