Benzinga | Dec 15, 2021 09:19AM EST

Edgewise Therapeutics To Report Phase 1b Topline Results Of EDG-5506 In Individuals With Becker Muscular Dystrophy On Jan. 5, 2022

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

-- Management to provide 2022 Company outlook at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022 --

BOULDER, Colo.--(BUSINESS WIRE)-- Edgewise 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).

"We look forward to sharing the Phase 1b BMD topline results of EDG-5506 during our webcast," said Joanne Donovan, M.D., Ph.D., ChiefMedical 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."

Further, 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.

Phase 1b BMD Topline Results Conference Call

Edgewise'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.

The 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 muscular dystrophy (DMD) in the second half of 2022.

About the ARCH Open Label Study

ARCH will evaluate EDG-5506 in adult males with BMD. Participants will include those who completed the Phase 1b first-in-human study of EDG-5506, as well as new participants. The study will assess a 10 mg dose of EDG-5506 administered daily over 3 months. Safety, PK and changes in biomarkers of muscle damage such as creatine kinase and fast troponin I will be evaluated.

Edgewise Therapeutics Presentation at J.P. Morgan Annual Healthcare Conference

Edgewise Therapeutics' President and Chief Executive Officer, Kevin Koch, Ph.D., will present at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 5:15 pm ET / 2:15 pm PT. The presentation will be webcast live; a link for the webcast can be found on the Edgewise events page and will be accessible for replay following the presentation. It is recommended that users connect to the webcast several minutes prior to the start to ensure a timely connection.