Business
Edgewise Therapeutics Reports Second Quarter 2021 Financial Results
– Continued to advance a Phase 1 MAD study of EDG-5506, a small molecule drug candidate designed to arrest muscle fiber breakdown in Duchenne and Becker
About this update from Edgewise Therapeutics, Inc.
[{"type":"text","content":"\n– Continued to advance a Phase 1 MAD study of EDG-5506, a small molecule drug candidate designed to arrest muscle fiber breakdown in Duchenne and Becker muscular dystrophy (DMD and BMD) –\n\n– Cash and marketable securities of $299 million as of June 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 rare muscle disorders, today reported financial results for the second quarter 2021 and recent business highlights.\n\n“We continue to make excellent progress on our pipeline of novel therapeutics for severe, rare muscle disorders,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “EDG-5506, our lead clinical candidate designed to protect injury-susceptible fast skeletal muscle fibers in Duchenne and Becker, is advancing in the clinic. We expect to have topline data from the Phase 1a MAD and Phase 1b Becker cohorts towards the end of 2021.”\n\nRecent Highlights\n\nContinued to Advance EDG-5506 in Clinical Development\n\nThe Phase 1 study of EDG-5506 is designed to evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in adult healthy volunteers (Phase 1a) and in adults with BMD (Phase 1b). EDG-5506 is advancing in the Multiple Ascending Dose (MAD) portion of the study. The Company expects to have topline MAD data in healthy volunteers and in BMD patients later in 2021.\n\nPresented Research at the New Directions in Biology and Disease of Skeletal Muscle Conference\n\nThe Company presented its research findings at the New Directions conference, describing the potential of selective fast myosin inhibition to provide broad protection against muscle injury in patients with DMD and BMD. These data support EDG-5506’s unique mechanism of action aimed at protecting injury-susceptible fast skeletal muscle fibers in DMD and BMD. The presentation can be viewed on the events and presentations page of the Edgewise website at www.edgewisetx.com.\n\n\nAdvanced Preclinical Research Programs\n\nEdgewise has developed a library of selective fast skeletal myosin inhibitors exhibiting a broad range of pharmacological and PK properties. The Company has characterized a faster onset alternative to EDG-5506 for the potential treatment of muscle spa...