Business
Edgewise Therapeutics Reports First Quarter 2022 Financial Results
– Completed enrollment of the ARCH open label study of EDG-5506 in Becker muscular dystrophy (BMD) – – Enrollment initiated in Edgewise-funded Natural
About this update from Edgewise Therapeutics, Inc.
[{"type":"text","content":"\n– Completed enrollment of the ARCH open label study of EDG-5506 in Becker muscular dystrophy (BMD) –\n– Enrollment initiated in Edgewise-funded Natural History Trial of BMD –\n– Phase 2 trials in BMD and Duchenne muscular dystrophy (DMD) planned to start in 2022 –\n– Cash, cash equivalents and marketable securities of $265.8 million as of March 31, 2022 –\n\n BOULDER, Colo.--(BUSINESS WIRE)--\nEdgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for the treatment of rare muscle disorders, today reported financial results for the first quarter of 2022 and recent business highlights.\n\n“2022 is off to a great start with the positive EDG-5506 data in individuals with BMD, a disorder for which there are no approved treatments,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “Based on these exciting results and the potential to bring EDG-5506 to the BMD and DMD communities, we are working with urgency on behalf of patients to initiate our Phase 2 trials in BMD in the coming weeks and in DMD later this year.”\n\nRecent Highlights\n\nEDG-5506 ARCH Study Completed Enrollment\n\nThe Company completed enrollment in the ARCH open label study that is evaluating EDG-5506 in 12 adult males with BMD. All those who participated the Phase 1b first-in-human study of EDG-5506 enrolled in the study. The study is evaluating multiple doses of EDG-5506 administered daily over 12 months. Safety, pharmacokinetics (PK), changes in biomarkers of muscle damage such as creatine kinase (CK) and fast skeletal muscle troponin (TNNI2), measures of function with North Star Ambulatory Assessments/ North Star Ambulatory Assessments Limb Girdle Type Muscular Dystrophies (NSAA/NSAD), time function tests and patient-reported outcomes, will be evaluated. The Company anticipates interim data from the ARCH trial during the second quarter of 2022. Go to clinicaltrials.gov to learn more about this study (NCT05160415).\n\nNatural History Study of Becker Muscular Dystrophy\n\nAn Edgewise-funded Natural History Trial of BMD is enrolling individuals. The trial is designed to understand the disease progression of individuals with BMD as assessed by functional measures and imaging endpoints. This global, multi-center trial is led by the GRASP (Ge...