Edgewise Therapeutics Strengthens Leadership Team to Support Late-Stage Clinical Development
Edgewise Therapeutics (NASDAQ: EWTX) announced key leadership changes to support its late-stage clinical development initiatives. Robert Blaustein, M.D., Ph.D. has been appointed as Chief Development Officer (CDO), bringing extensive cardiovascular drug development experience from Merck, where he led the successful development and approval of vericiguat for heart failure treatment. Behrad Derakhshan, Ph.D. has been promoted from Chief Business Officer to Chief Operating Officer (COO).
The company recently reported positive topline data from EDG-7500's Phase 1 trial in healthy subjects and the single-dose arm (part A) of the Phase 2 CIRRUS-HCM trial in patients with obstructive hypertrophic cardiomyopathy (HCM). The company has begun enrolling patients in the 28-day arms (parts B and C) and 12-week open label extension (part D) of the CIRRUS-HCM trial for both obstructive and non-obstructive HCM patients.
Edgewise Therapeutics (NASDAQ: EWTX) ha annunciato importanti cambiamenti nel vertice per sostenere le proprie iniziative di sviluppo clinico nelle fasi avanzate. Robert Blaustein, M.D., Ph.D. è stato nominato Chief Development Officer (CDO), portando con sé una vasta esperienza nello sviluppo di farmaci cardiovascolari proveniente da Merck, dove ha guidato con successo lo sviluppo e l'approvazione del vericiguat per il trattamento dell'insufficienza cardiaca. Behrad Derakhshan, Ph.D. è stato promosso da Chief Business Officer a Chief Operating Officer (COO).
Recentemente, l'azienda ha riportato dati positivi dal trial di Fase 1 dell'EDG-7500 su soggetti sani e dal braccio a dose singola (parte A) del trial di Fase 2 CIRRUS-HCM in pazienti con cardiomiopatia ipertrofica ostruttiva (HCM). L'azienda ha iniziato a reclutare pazienti per i bracci di 28 giorni (parti B e C) e per l'estensione in aperto di 12 settimane (parte D) del trial CIRRUS-HCM per pazienti affetti sia da HCM ostruttiva che non ostruttiva.
Edgewise Therapeutics (NASDAQ: EWTX) anunció cambios clave en el liderazgo para apoyar sus iniciativas de desarrollo clínico en etapas avanzadas. Robert Blaustein, M.D., Ph.D. ha sido nombrado Director de Desarrollo (CDO), aportando una amplia experiencia en el desarrollo de fármacos cardiovasculares de Merck, donde lideró con éxito el desarrollo y la aprobación de vericiguat para el tratamiento de la insuficiencia cardíaca. Behrad Derakhshan, Ph.D. ha sido ascendido de Director de Negocios a Director de Operaciones (COO).
Recientemente, la empresa informó datos positivos del trial de Fase 1 de EDG-7500 en sujetos sanos y del brazo de dosis única (parte A) del trial de Fase 2 CIRRUS-HCM en pacientes con cardiomiopatía hipertrófica obstructiva (HCM). La empresa ha comenzado a reclutar pacientes para los brazos de 28 días (partes B y C) y la extensión abierta de 12 semanas (parte D) del ensayo CIRRUS-HCM para pacientes con HCM obstructiva y no obstructiva.
Edgewise Therapeutics (NASDAQ: EWTX)는 후기 단계 임상 개발 이니셔티브를 지원하기 위해 주요 리더십 변화를 발표했습니다. Robert Blaustein, M.D., Ph.D.가 최고 개발 책임자(CDO)로 임명되었으며, 그는 머크에서 심혈관 약물 개발에 대한 풍부한 경험을 쌓았고, 심부전 치료를 위한 베리시구아트의 성공적인 개발과 승인을 이끌었습니다. Behrad Derakhshan, Ph.D.는 최고 비즈니스 책임자에서 최고 운영 책임자(COO)로 승진했습니다.
최근 회사는 건강한 피험자에 대한 EDG-7500의 1상 시험에서 긍정적인 주요 데이터를 보고했으며, 차단성 비대 심근병증(HCM) 환자에 대한 2상 CIRRUS-HCM 시험의 단일 투약 팔(파트 A)에서 긍정적인 결과를 나타냈습니다. 회사는 차단성 HCM 및 비차단성 HCM 환자 모두를 위한 CIRRUS-HCM 시험의 28일 팔(파트 B 및 C) 및 12주 개방형 확장(파트 D)에서 환자 등록을 시작했습니다.
Edgewise Therapeutics (NASDAQ: EWTX) a annoncé d'importants changements de direction pour soutenir ses initiatives de développement clinique en phase avancée. Robert Blaustein, M.D., Ph.D. a été nommé Directeur du Développement (CDO), apportant une vaste expérience dans le développement de médicaments cardiovasculaires de Merck, où il a dirigé le développement et l'approbation réussis de vericiguat pour le traitement de l'insuffisance cardiaque. Behrad Derakhshan, Ph.D. a été promu de Directeur Commercial à Directeur des Opérations (COO).
Récemment, l'entreprise a rapporté des données positives des essais de Phase 1 de l'EDG-7500 sur des sujets sains et sur le bras à dose unique (partie A) de l'essai de Phase 2 CIRRUS-HCM chez des patients atteints de cardiomyopathie hypertrophique obstructive (HCM). L'entreprise a commencé à recruter des patients pour les bras de 28 jours (parties B et C) et l'extension ouverte de 12 semaines (partie D) de l'essai CIRRUS-HCM pour des patients atteints de HCM obstructive et non obstructive.
Edgewise Therapeutics (NASDAQ: EWTX) gab wichtige Führungswechsel bekannt, um seine klinischen Entwicklungsinitiativen in der späten Phase zu unterstützen. Robert Blaustein, M.D., Ph.D. wurde zum Chief Development Officer (CDO) ernannt und bringt umfangreiche Erfahrungen in der Entwicklung von kardiovaskulären Arzneimitteln von Merck mit, wo er die erfolgreiche Entwicklung und Zulassung von Vericiguat zur Behandlung von Herzinsuffizienz leitete. Behrad Derakhshan, Ph.D. wurde vom Chief Business Officer zum Chief Operating Officer (COO) befördert.
Das Unternehmen berichtete kürzlich über positive Gesamtdaten aus der Phase-1-Studie von EDG-7500 an gesunden Probanden und dem Einzel-Dosis-Arm (Teil A) der Phase-2-CIRRUS-HCM-Studie bei Patienten mit obstruktiver hypertropher Kardiomyopathie (HCM). Das Unternehmen hat mit der Rekrutierung von Patienten für die 28-tägigen Arme (Teile B und C) und die 12-wöchige offene Verlängerung (Teil D) der CIRRUS-HCM-Studie für Patienten mit obstruktiver und nicht-obstruktiver HCM begonnen.
- Appointment of experienced CDO with successful track record in cardiovascular drug development
- Positive topline data reported from EDG-7500 Phase 1 trial
- Advancement of CIRRUS-HCM trial with multiple ongoing trial arms
- Milestone timelines for cardiovascular program remain unchanged
- Departure of current CDO Dr. Semigran
Insights
While management changes often don't significantly impact stock performance, these appointments signal Edgewise Therapeutics' strategic evolution towards commercialization. The company's lead asset, EDG-7500, is advancing through Phase 2 trials for hypertrophic cardiomyopathy (HCM), a condition affecting approximately 1 in 500 people globally.
Dr. Blaustein's appointment is particularly noteworthy due to his track record at Merck, where he successfully led the development and approval of vericiguat for heart failure. His expertise in cardiovascular drug development and regulatory navigation could be important for EDG-7500's clinical progress. The CIRRUS-HCM trial is now actively enrolling patients in multiple arms, including a 28-day treatment period and a 12-week open-label extension.
Dr. Derakhshan's promotion to COO, following his successful oversight of the company's IPO and subsequent funding rounds, suggests a heightened focus on operational efficiency and commercial preparedness. For investors, these organizational changes indicate the company is positioning itself for potential commercialization, though significant clinical and regulatory hurdles remain.
For retail investors less familiar with biotech: Think of this as Edgewise bringing in a seasoned pilot (Dr. Blaustein) who has successfully landed similar planes before, while promoting their successful fundraising expert (Dr. Derakhshan) to ensure the whole airport runs smoothly. The company is transitioning from the research phase to preparing for potential market entry, though final approval is still not guaranteed.
- Robert Blaustein, M.D., Ph.D. appointed as Chief Development Officer (CDO) -
- Behrad Derakhshan, Ph.D. promoted to Chief Operating Officer (COO) -
Robert Blaustein, M.D., Ph.D., Chief Development Officer, Edgewise Therapeutics (Photo: Business Wire)
"These leadership changes signify our organization's progression into late-stage clinical development, setting the stage for the future commercialization of our novel therapeutics," said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise Therapeutics. "As we welcome Rob, it’s an exciting time for the Company, and we are fortunate to have a highly experienced executive team guiding us forward."
Robert Blaustein, M.D., Ph.D., joins the Company as Chief Development Officer, responsible for leading EDG-7500, a novel cardiac sarcomere modulator in Phase 2 development, as well as the cardiovascular and cardiometabolic pipeline. With significant depth of experience in cardiovascular drug development, Dr. Blaustein joins from Merck where he was most recently Associate Vice President and the Atherosclerosis Section Head in the Atherosclerosis and Metabolism Clinical Research Department, leading all late phase development efforts in this area. During his 15+ years at Merck, Dr. Blaustein contributed to clinical programs across a range of cardiovascular targets and led clinical development in the atherosclerosis and heart failure spaces. Importantly, he led the vericiguat development team through the completion of the Phase 3 VICTORIA heart failure trial, subsequent regulatory filing and global approval of vericiguat for the treatment of patients with worsening heart failure, a collaborative effort with Bayer AG. Dr. Blaustein obtained his undergraduate degree in mathematics from Wesleyan University. His post-graduate training included medical residency at Brigham and Women’s Hospital, cardiology fellowship at Massachusetts General Hospital, and an HHMI post-doctoral fellowship in the Biochemistry Department at Brandeis University. He subsequently served on the faculty of Tufts Medical Center prior to joining Merck.
Dr. Semigran, current CDO, will depart from the Company and will serve as a clinical advisor for a period to ensure a smooth transition. “On behalf of the Board of Directors and the entire Edgewise organization, I want to thank Marc for his leadership and contributions to our cardiovascular program,” said Dr. Koch. "Marc played a prominent role in successfully advancing EDG-7500 in the clinic.” Most recently the Company reported positive topline data of EDG-7500 in the Phase 1 trial in healthy subjects and from the single-dose arm (part A) of the Phase 2 CIRRUS-HCM trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Further, the Company opened and began enrolling the 28-day arms (parts B and C) and the 12-week open label extension (part D) of the CIRRUS-HCM trial in patients with obstructive HCM and non-obstructive HCM. There are no changes in previously described milestone timelines for the Company’s cardiovascular program.
Behrad Derakhshan, Ph.D., joined Edgewise in 2020 as Chief Business Officer, leading the Company’s efforts in strategic planning, business development, capital formation, investor relations, corporate communications and commercial planning. He was instrumental through the Company’s highly successful initial public offering, played a key role securing several additional funding rounds and driving the strategic direction of the organization. Dr. Derakhshan’s leadership and vision have been instrumental in fueling Edgewise’s growth and success to date. As COO, Dr. Derakhshan will be responsible for enabling the operational readiness of the organization as the Company approaches significant milestones in the muscular dystrophy and cardiovascular programs, moving toward a commercial-ready biopharmaceutical company.
These changes to the Edgewise executive team are effective immediately.
About Edgewise Therapeutics
Edgewise Therapeutics is a leading muscle disease biopharmaceutical company developing novel therapeutics for muscular dystrophies and serious cardiac conditions. The Company’s deep expertise in muscle physiology is driving a new generation of novel therapeutics. Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor in late-stage clinical trials in Becker and Duchenne muscular dystrophies. EDG-7500 is a novel cardiac sarcomere modulator for the treatment of hypertrophic cardiomyopathy and other diseases of diastolic dysfunction, currently in Phase 2 clinical development. The entire team at Edgewise is dedicated to our mission: changing the lives of patients and families affected by serious muscle diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn, X , Facebook and Instagram.
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Edgewise Contacts
Investors:
Michael Carruthers, Chief Financial Officer
ir@edgewisetx.com
Media:
Maureen Franco, VP Corporate Communications
media@edgewisetx.com
Source: Edgewise Therapeutics
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