Business
Edgewise Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights
– Advancing Phase 2 trials of EDG-5506 in Becker muscular dystrophy (BMD, CANYON) and Duchenne muscular dystrophy (DMD, LYNX) – – Advancing exercise
About this update from Edgewise Therapeutics, Inc.
[{"type":"text","content":"\n– Advancing Phase 2 trials of EDG-5506 in Becker muscular dystrophy (BMD, CANYON) and Duchenne muscular dystrophy (DMD, LYNX) –\n\n\n– Advancing exercise challenge study of EDG-5506 in Limb girdle muscular dystrophy 2I, BMD and McArdle Disease (LGMD2I/R9, BMD, McArdle, DUNE) –\n\n\n– Advancing IND-enabling studies of EDG-7500, a novel sarcomere modulator for hypertrophic cardiomyopathy (HCM); Phase 1 start expected in 2H2023 –\n\n\n– Cash, cash equivalents and marketable securities of $328 million as of March 31, 2023 –\n\n\n BOULDER, Colo.--(BUSINESS WIRE)--\nEdgewise Therapeutics, Inc. (Nasdaq: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for the treatment of devastating muscle disorders, today reported financial results for the first quarter of 2023 and recent business highlights.\n\n\n“We’re off to a great start in 2023! The team has focused on advancing our LYNX and CANYON clinical trials of EDG-5506 in addition to completing IND-enabling studies of EDG-7500, our novel sarcomere modulator for HCM,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “During the remainder of 2023, we expect to share 12-month ARCH open label data and interim Duchenne data from our Phase 2 LYNX trial. We also plan to initiate a potentially registration-enabling cohort in CANYON and a Phase 1 trial for EDG-7500 in healthy volunteers.”\n\n\nRecent Highlights\n\n\nAdvancing CANYON Clinical Trial of EDG-5506 in Individuals with BMD\n\n\nThe Company is continuing to recruit the CANYON clinical trial evaluating EDG-5506 in individuals with BMD. CANYON is assessing the effect of EDG-5506 over a 12-month period on safety, pharmacokinetics (PK), biomarkers of muscle damage, such as creatine kinase (CK) and fast skeletal muscle troponin I, fat fraction as measured by muscle MRI and function in individuals with BMD aged 12 to 50 years. This placebo-controlled trial is anticipated to recruit approximately 32 adults and 18 adolescents at up to 14 sites in the United States, United Kingdom and the Netherlands. The Company plans to amend the CANYON study to include a potentially registration-enabling cohort in the second half of 2023. Go to clinicaltrials.gov to learn more about this trial (NCT05291091).\n\n\n\n\nAdvancing LYNX Phase 2 Clinical Trial o...