Business
Edgewise Therapeutics Reports Fourth Quarter and Full Year 2022 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); Initiated Phase 2 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); Initiated Phase 2 exercise challenge trial of EDG-5506 in Limb girdle muscular dystrophy 2i (LGMD2I), BMD and McArdle’s Disease (DUNE) –\n\n– Initiated IND-enabling studies of EDG-7500, a novel sarcomere modulator for hypertrophic cardiomyopathy (HCM); Phase 1 start expected in 2H2023 –\n\n– Cash, cash equivalents and marketable securities of $352 million as of December 31, 2022 –\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 fourth quarter and full year of 2022 and recent business highlights.\n\n“In 2022, we made significant progress advancing our LYNX, CANYON, ARCH and DUNE clinical trials, notably with the 6-month data from the ARCH open label study in individuals with BMD, which reinforces our confidence behind EDG-5506. Moreover, our discovery platform continues to yield differentiated precision medicines, exemplified by EDG-7500, a novel sarcomere modulator for HCM which has entered IND-enabling studies,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “In 2023, we see continued momentum for our growing pipeline, including a planned 12-month BMD readout from our ARCH open label study, interim DMD data from our Phase 2 LYNX trial, a potentially registration-enabling cohort in CANYON and a Phase 1 trial for EDG-7500 in HCM.”\n\nRecent Highlights\n\nAdvancing CANYON Clinical Trial of EDG-5506 in Individuals with BMD\nThe Company is continuing to advance the CANYON clinical trial evaluating EDG-5506 in individuals with BMD. CANYON will assess the effect of EDG-5506 over a 12-month period on safety, pharmacokinetics (PK), biomarkers such as creatine kinase (CK) and fast skeletal muscle troponin I, fat fraction as measured by muscle MRI and functional measures in individuals with BMD aged 12 to 50 years. This placebo-controlled trial is anticipated to recruit approximately 66 individuals at up to 14 sites in the United States, United Kingdom and Netherlands. The Company expects to amend the CANYON study to include a potentially re...