PPMD is excited to share that Edgewise Therapeutics has announced CANYON, their Phase 2 study of EDG-5506 in individuals with Becker, is now enrolling. EDG-5506 is a small molecule, taken orally, that is intended to help protect muscle by reducing injury of fast-twitch skeletal muscle.
The placebo-controlled Phase 2 study is enrolling individuals with Becker that are 12 years or older, who will be followed for 12-months. The primary focus of the study is safety, but Edgewise will monitor a number of blood and imaging biomarkers, in addition to functional outcome measures.
The trial aims to enroll 66 patients across 14 sites in the United States, UK, and Netherlands. To learn more about the study please visit clinicaltrials.gov (NCT05291091).
Read the Press Release from Edgewise Therapeutics:
Edgewise Therapeutics Now Enrolling CANYON Phase 2 Clinical Trial Of EDG-5506 In Individuals With Becker Muscular Dystrophy (BMD)
JULY, 12, 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 the initiation of the CANYON Phase 2 clinical trial evaluating EDG-5506 in individuals with BMD. EDG-5506 is an orally administered small molecule myosin modulator designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies such as BMD and Duchenne muscular dystrophy (DMD). There are currently no approved treatments for 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 functional measures in individuals with BMD aged 12 years and above. This placebo-controlled trial is anticipated to recruit approximately 66 individuals at up to 14 sites in the United States, United Kingdom and Netherlands. To learn more about this trial (NCT05291091), go to clinicaltrials.gov.
“We are delighted to advance EDG-5506 into Phase 2, based on the safety and positive biomarker data observed in our Phase 1 and ARCH studies,” said Joanne Donovan, M.D., Ph.D., Chief Medical Officer of Edgewise. “In the CANYON trial, we aim to understand the effect of EDG-5506 on circulating biomarkers, muscle MRI, and functional measures, all of which could provide indications of a treatment effect.”
“I look forward to working with fellow investigators and the BMD community on this Phase 2 trial of EDG-5506,” said Brenda L. Wong, M.D., Clinical Director, Duchenne Muscular Dystrophy Center, UMass Memorial Medical Center and Professor of Pediatrics and Neurology, University of Massachusetts Medical School. “Individuals with BMD and their families have been waiting for a while for clinical trials and it is indeed an exciting time to be a part of this trial. BMD is a serious, progressive, debilitating neuromuscular disorder, which causes great hardship to individuals with BMD and their families and caregivers.”