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Edgewise Therapeutics to Report Phase 1b Topline Results of EDG-5506 in Individuals with Becker Muscular Dystrophy (BMD) on January 5, 2022, and Initiates ARCH Follow-On Open Label BMD Study

– Webcast event to feature EDG-5506 topline results presentation and commentary by a leading neuromuscular disease expert – – Management to provide 2022

articleEdgewise Therapeutics, Inc.December 15, 20214/company/edgewise-therapeutics-inc/news/edgewise-therapeutics-to-report-phase-1b-topline-results-of-edg-5506-in-individuals
Edgewise Therapeutics to Report Phase 1b Topline Results of EDG-5506 in Individuals with Becker Muscular Dystrophy (BMD) on January 5, 2022, and Initiates ARCH Follow-On Open Label BMD Study

About this update from Edgewise Therapeutics, Inc.

[{"type":"text","content":"\n– Webcast event to feature EDG-5506 topline results presentation and commentary by a leading neuromuscular disease expert –\n\n– Management to provide 2022 Company outlook at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 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 announced plans to report topline results from the Phase 1b clinical trial of EDG-5506 in individuals with BMD on January 5, 2022, at 9:00 am ET. The webcast event will feature a presentation of the results which support advancement of the program, and commentary by a leading neuromuscular disease expert. Additionally, the Company will provide details on the recently initiated follow-on open label study, EDG-5506-002 (ARCH).\n\n“We look forward to sharing the Phase 1b BMD topline results of EDG-5506 during our webcast,” said Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Edgewise. “We are also excited to initiate the ARCH study, which will enroll participants from our Phase 1b clinical trial as well as new participants with BMD.”\n\nFurther, Edgewise plans to share these findings and the Company’s 2022 outlook at the 40th Annual J.P. Morgan Healthcare conference on January 10, 2022.\n\nPhase 1b BMD Topline Results Conference Call\n\nEdgewise’s management will hold a conference call and webcast on January 5, 2022, at 9:00 am ET to discuss topline results from the Phase 1b clinical trial in individuals with BMD. To participate, please dial 844-200-6205 (domestic) or 929-526-1599 (international) and refer to access code 078871. Visit the Edgewise events page to access the webcast, including replay and conference call slides.\n\nThe Phase 1b clinical trial enrolled 7 participants and assessed a 20 mg dose of EDG-5506 (n=5) or placebo (n=2) for 14 days. The clinical trial was designed to evaluate safety, pharmacokinetics (PK) and changes in biomarkers of muscle damage, such as creatine kinase and fast troponin I as well as biomarkers evaluated using SOMAscan, in adult males with BMD. Based on the clinical results to date, the Company expects to initiate Phase 2 clinical trials in individuals with BMD in the first half of 2022 and Duchenne mus...

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