Business
Edgewise Therapeutics Reports Third Quarter 2021 Financial Results
– Announced positive topline results from the EDG-5506 Phase 1 multiple ascending dose (MAD) study in healthy volunteers (HV) – – Dosed first Becker muscular
About this update from Edgewise Therapeutics, Inc.
[{"type":"text","content":"\n– Announced positive topline results from the EDG-5506 Phase 1 multiple ascending dose (MAD) study in healthy volunteers (HV) –\n\n– Dosed first Becker muscular dystrophy (BMD) patients with EDG-5506 as part of the ongoing Phase 1b trial –\n\n– Phase 2 trials in BMD and Duchenne muscular dystrophy (DMD) expected to start in 2022 –\n\n– Cash and marketable securities of $290 million as of September 30, 2021 –\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 reported financial results for the third quarter 2021 and recent business highlights.\n\n“We achieved a significant milestone with our positive topline results from the EDG-5506 Phase 1 MAD study, which support advancing the program into individuals with Becker and Duchenne,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “As we look to the remainder of 2021 and into 2022, I am very excited about the Company’s potential as we continue to advance and expand the EDG-5506 program and our research programs. Our experienced team is working with urgency to help make a difference in the lives of individuals with rare muscle disorders.”\n\nRecent Highlights\n\nAnnounced Positive Topline Results from the EDG-5506 Phase 1 MAD Study in HVs and Dosed First BMD Patients\n\nThe Company announced positive topline results from the MAD portion of a first-in-human Phase 1 clinical trial assessing the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of escalating doses of EDG-5506, an orally administered small molecule myosin inhibitor designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies such as DMD and BMD.\n\nEDG-5506 was shown to be generally well tolerated at all doses studied with no adverse events seen in laboratory values, electrocardiograms or other vital signs. The most common adverse events were dizziness and somnolence, which were mild, transient and self-resolving. At projected therapeutic levels, as exposure increased over time, the incidence of adverse events generally decreased, suggesting development of tolerance. PK data demonstrated robust target engagement with high muscle exposures consistent with ...