Edgewise Therapeutics, Inc. (NASDAQ : EWTX), which is a clinical-stage biopharmaceutical firm that develops targeted, orally bioavailable small molecule therapies for people with severe muscle disorders, announced today Marc Semigran, M.D., was appointed Chief Development Officer. Edgewise's Chief Development Officer is Dr. Marc Semigran, who has extensive clinical and translational medical experience. He was most recently the Chief Medical Officer (CMO), at Renovacor, Inc., following its acquisition by Rocket Pharmaceuticals, Inc., and was previously the CMO and Senior Vice President for medical science at MyoKardia, which was acquired by Bristol Myers Squibb in 2020, costing $13.1 billion. He will lead Edgewise's cardiovascular development.
"We are delighted to welcome Marc to our team and are eager for us to start working together as we advance our novel cardiac programme into clinical development," said Kevin Koch, Ph.D. Chief Executive Officer. "Marc's expertise in cardiovascular drug development will be invaluable as our cardiac program moves towards an anticipated IND filing during the second half 2023.
Dr. Semigran stated that he was impressed by Edgewise's precision medicine drug discovery platform, and innovative scientific approach to treating progressive and severe muscle disorders. "At Edgewise we are currently developing the next generation treatments that target the underlying mechanisms of patients with severe heart failure and unmet medical needs. My experience as a cardiac physician and researcher in cardiomyopathy drug discovery will be a valuable asset to Edgewise's efforts to improve its cardiac therapeutic programs.
Dr. Semigran spent his time at MyoKardia building and expanding his research and development teams to be able to implement successful translational and developmental programs, including the development of mavacamten for patients suffering from obstructive hypertrophic cardiac cardiomyopathy. Dr. Semigran was responsible for the implementation of Phase 1 and 2, the design of registrational trials, and interactions with international regulatory authorities. He also assisted in the mavacamten New Drug Application filing following MyoKardia's acquisition. Camzyos(r), (mavacamten), was approved by the U.S. Food and Drug Administration in April 2022 for treatment of adults suffering from obstructive cardiomyopathy.
Before entering the biotechnology sector, Dr. Semigran was the Section Head and Medical Director of the Massachusetts General Hospital Heart Failure and Cardiac Transplant Program. He was also the Director of the Harvard Regional Clinical Center for the National Heart, Lung, and Blood Institute Heart Failure Network and a Principal Investigator in a multicenter heart disease trial sponsored by NHLBI. For more than 30 years, Dr. Semigran was part of the Massachusetts General Hospital cardiology and internal medicine faculty. He was also an associate professor at Harvard Medical School.
More than 160 peer-reviewed papers have been published by Dr. Semigran in the areas of cardiomyopathy, heart disease, and transplantation. He also served as editor for a major textbook on heart disease. He has been the recipient of many industry and National Institutes of Health research awards. He also served as co-investigator or principal investigator in major clinical trials in various therapeutic areas. He has also served as a scientific and medical advisor to Medtronic, Bayer, and GlaxoSmithKline.
Dr. Semigran holds A.B., A.M. and M.D. degrees. Harvard University. He received his cardiology and internal medicine fellowship training at Massachusetts General Hospital.
Edgewise Therapeutics, a clinical-stage biopharmaceutical firm, focuses on the development and commercialization innovative treatments for rare, severe, and serious musculoskeletal, cardiac, and other disorders. Edgewise's holistic approach to drug discovery has made it possible to create a muscle-focused drug discovery platform. This is thanks to its expertise in small molecule engineering and muscle biology. Edgewise's platform uses custom-built, high throughput, and translatable systems to measure muscle function in whole organ extracts. This allows for the identification of small molecule precision medicines that regulate key proteins in muscle tissue. EDG-5506, an investigational oral small molecule myosin moderator that protects injury-susceptible fast muscle fibers in dystrophinopathies is the Company's lead candidate. It has been in multiple clinical trials with individuals with Duchenne muscular disorder and Becker muscular dystrophy. For more information, visit: URL. You can also follow us on LinkedIn and Twitter.
Forward-Looking Statements: Cautionary Note
Forward-looking statements are those that are not historical and as such, this press release includes them. Forward-looking statements are made in this press release even if they are not historical. These forward-looking statements include statements regarding Edgewise’s drug discovery platform and product candidates, as well statements regarding the expected timing of filing an IND to Edgewise’s cardiac program. They also include statements made by Edgewise’s president and chief executive officers, and Edgewise’s chief development officer. Forward-looking statements can be identified by words such as "believes", "anticipates," "plans,"..."plans,"..."intends,"... and similar expressions. These forward-looking statements are based on Edgewise's current expectations. They may not prove to be accurate or come true. Due to numerous uncertainties and risks, actual results may differ materially from what is projected in forward-looking statements. These include the risks associated with discovering, developing, and commercializing safe and effective drugs for human therapeutics. Edgewise's capability to initiate, complete, and obtain approvals for preclinical trials and clinical studies for any of its product candidate; Edgewise’s manufacturing, marketing, and strategy capabilities; the size and potential impact of COVID-19 pandemic; the ability of Edgewise to create a proprietary drug discovery platform; the company; reliance on other parties; Edgewise to maintain its intellectual property rights; Edgewise’s products; market conditions and general economic and the economy and the ability to protect its product candidates and to obtain and to its product; market and to protect its product candidates and to their product; market and to the product; market conditions and the product candidates and to the product; as well as well as well as well as well as well as well as well as well as well as to the if they are not to get and to obtain and to keep the s to obtain and to protect its s Additional information regarding these and other risks can be found in the section entitled "Risk Factors" in the documents Edgewise files with the U.S. Securities and Exchange Commission. Businesswire.com: URL