Trevi Therapeutics Announces Appointment of James V. Cassella, Ph.D., as Chief Development Officer
Trevi Therapeutics (Nasdaq: TRVI) has appointed James V. Cassella, Ph.D., as Chief Development Officer (CDO). Dr. Cassella, who has been a board member for four years, brings over 35 years of experience in CNS drug development. He will play a important role in advancing Haduvio™, Trevi's investigational therapy for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).
Dr. Cassella's extensive background includes successful drug approvals and leadership roles at companies like Concert Pharmaceuticals and Alexza Pharmaceuticals. He replaces Dr. David Clark, who has stepped down as Chief Medical Officer but will continue to consult for the company.
Trevi is preparing for Haduvio's pivotal development program in IPF, advancement in RCC, and regulatory submission. The company anticipates upcoming data read-outs, which Dr. Cassella will help navigate with his expertise in late-stage CNS drug development and regulatory experience.
Trevi Therapeutics (Nasdaq: TRVI) ha nominato James V. Cassella, Ph.D., come Chief Development Officer (CDO). Il Dr. Cassella, che è stato membro del consiglio per quattro anni, porta con sé oltre 35 anni di esperienza nello sviluppo di farmaci per il sistema nervoso centrale (CNS). Svolgerà un ruolo importante nell'avanzamento di Haduvio™, la terapia in fase di sperimentazione di Trevi per la tosse cronica nella fibrosi polmonare idiopatica (IPF) e nella tosse cronica refrattaria (RCC).
Il vasto background del Dr. Cassella include approvazioni di farmaci di successo e ruoli di leadership in aziende come Concert Pharmaceuticals e Alexza Pharmaceuticals. Sostituisce il Dr. David Clark, che si è dimesso dalla carica di Chief Medical Officer ma continuerà a offrire consulenza per l'azienda.
Trevi si sta preparando per il programma di sviluppo cruciale di Haduvio nell'IPF, l'avanzamento nella RCC e la presentazione normativa. L'azienda prevede imminenti risultati di studio che il Dr. Cassella aiuterà a gestire grazie alla sua esperienza nello sviluppo di farmaci CNS in fase avanzata e nella regolamentazione.
Trevi Therapeutics (Nasdaq: TRVI) ha nombrado a James V. Cassella, Ph.D., como Director de Desarrollo (CDO). El Dr. Cassella, quien ha sido miembro de la junta durante cuatro años, aporta más de 35 años de experiencia en el desarrollo de medicamentos para el sistema nervioso central (SNC). Desempeñará un papel importante en el avance de Haduvio™, la terapia en investigación de Trevi para la tos crónica en la fibrosis pulmonar idiopática (FPI) y la tos crónica refractaria (TCR).
El amplio fondo del Dr. Cassella incluye aprobaciones exitosas de medicamentos y roles de liderazgo en empresas como Concert Pharmaceuticals y Alexza Pharmaceuticals. Reemplaza al Dr. David Clark, quien ha renunciado como Director Médico pero continuará consultando para la empresa.
Trevi se está preparando para el programa de desarrollo crucial de Haduvio en la FPI, el avance en la TCR y la presentación regulatoria. La empresa anticipa próximos resultados de datos, que el Dr. Cassella ayudará a gestionar con su experiencia en el desarrollo de medicamentos del SNC en etapas avanzadas y su experiencia regulatoria.
Trevi Therapeutics (Nasdaq: TRVI)가 James V. Cassella, Ph.D.를 최고 개발 책임자(CDO)로 임명했습니다. Cassella 박사는 4년간 이사로 활동하며 CNS 약물 개발 분야에서 35년 이상의 경험을 쌓았습니다. 그는 Trevi의 만성 기침 치료제 Haduvio™의 발전에 중요한 역할을 할 것입니다. 이 치료제는 특발성 폐섬유증(IPF)과 난치성 만성 기침(RCC)을 대상으로 하고 있습니다.
Cassella 박사는 Concert Pharmaceuticals 및 Alexza Pharmaceuticals와 같은 회사에서 성공적인 약물 승인 및 리더십 역할을 맡아온 방대한 경력을 가지고 있습니다. 그는 최고 의학 책임자에서 물러난 Dr. David Clark를 대신하게 되며, Clark 박사는 계속해서 회사에 자문을 제공할 예정입니다.
Trevi는 IPF에서 Haduvio의 중요한 개발 프로그램을 준비하고 있으며, RCC에서도 발전을 이루고 규제 제출을 계획하고 있습니다. 회사는 곧 데이터 발표를 예상하고 있으며, Cassella 박사는 후기 단계 CNS 약물 개발과 규제 경험을 바탕으로 이를 이끌어 갈 것입니다.
Trevi Therapeutics (Nasdaq: TRVI) a nommé James V. Cassella, Ph.D., en tant que Directeur du Développement (CDO). Le Dr Cassella, qui est membre du conseil d'administration depuis quatre ans, apporte plus de 35 ans d'expérience dans le développement de médicaments pour le système nerveux central (SNC). Il jouera un rôle important dans l'avancement de Haduvio™, la thérapie expérimentale de Trevi pour la toux chronique dans la fibrose pulmonaire idiopathique (FPI) et la toux chronique réfractaire (TCR).
Le vaste parcours du Dr Cassella inclut des approbations de médicaments réussies et des postes de direction dans des entreprises telles que Concert Pharmaceuticals et Alexza Pharmaceuticals. Il remplace le Dr David Clark, qui a démissionné de son poste de Directeur Médical mais continuera à conseiller l'entreprise.
Trevi se prépare au programme de développement clé de Haduvio dans la FPI, à l'avancement dans la TCR et à la soumission réglementaire. L'entreprise anticipe des résultats de données à venir, que le Dr Cassella aidera à gérer grâce à son expertise dans le développement de médicaments du SNC en phase avancée et son expérience réglementaire.
Trevi Therapeutics (Nasdaq: TRVI) hat James V. Cassella, Ph.D., zum Chief Development Officer (CDO) ernannt. Dr. Cassella, der seit vier Jahren Mitglied des Vorstands ist, bringt über 35 Jahre Erfahrung in der Entwicklung von CNS-Medikamenten mit. Er wird eine wichtige Rolle bei der Weiterentwicklung von Haduvio™, Trevis experimenteller Therapie gegen chronischen Husten bei idiopathischer Lungenfibrose (IPF) und refraktärem chronischen Husten (RCC) spielen.
Dr. Cassellas umfassender Hintergrund umfasst erfolgreiche Arzneimittelzulassungen und Führungspositionen in Unternehmen wie Concert Pharmaceuticals und Alexza Pharmaceuticals. Er ersetzt Dr. David Clark, der als Chief Medical Officer zurückgetreten ist, aber weiterhin beratend für das Unternehmen tätig sein wird.
Trevi bereitet sich auf das entscheidende Entwicklungsprogramm von Haduvio bei IPF, das Vorankommen bei RCC und die regulatorische Einreichung vor. Das Unternehmen erwartet in Kürze Ergebnisse, für die Dr. Cassella mit seiner Expertise in der späten Phase der CNS-Medikamentenentwicklung und seiner regulatorischen Erfahrung unterstützen wird.
- Appointment of experienced CDO with 35+ years in CNS drug development
- New CDO has prior knowledge of Haduvio as a board member
- Strengthened leadership for pivotal development program and regulatory submission
- Retention of former CMO as consultant
- Departure of Chief Medical Officer
"I am delighted to welcome Jim, who has been a member of our Board of Directors for the past four years, to our executive management team as Chief Development Officer," said Jennifer Good, President and CEO of Trevi Therapeutics. "Our team is planning for the pivotal development program in IPF, the advancement in refractory chronic cough, and preparing for a regulatory submission of Haduvio. Jim will play an integral role in progressing Haduvio by utilizing his broad drug development experience and his proven hands-on leadership of scientific and regulatory teams through drug approvals. In particular, his extensive experience and execution in central nervous system (CNS) drug development together with his long-standing knowledge of Haduvio as a member of our board of directors, positions him to make an immediate impact at this important time for the Company."
"I am very excited to join the team at Trevi in a direct leadership role as I see the great potential that Haduvio's central and peripheral mechanism could have on treating patients suffering from chronic cough conditions," said Dr. Cassella. "It is a very important time at Trevi with the upcoming data read-outs and I look forward to leveraging my late-stage CNS drug development and regulatory experience to advance Haduvio through to approval."
Dr. Cassella has over 35 years of experience working in innovative publicly traded drug and product development companies with a specific focus on CNS therapies. Prior to joining Trevi as CDO, Dr. Cassella served as CDO for Concert Pharmaceuticals (acquired by Sun Pharma in 2023) where he spearheaded the development activities leading to the successful US FDA approval of the autoimmune JAK inhibitor, Leqselvi™. At Concert Pharmaceuticals, he was a key member of the Executive Team and the corporate transaction team leading to its
Dr. Cassella will replace Dr. David Clark, who has stepped down as Chief Medical Officer to help with the care of an immediate family member but will continue to consult for the Company. "We want to thank David for his contributions at Trevi and wish him and his family the best," said Good.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Haduvio is a dual ĸ-opioid receptor agonist and µ-opioid receptor antagonist that works both centrally in the brain as well as peripherally in the lungs and has the potential for a synergistic antitussive effect to treat chronic cough. Parenteral nalbuphine is not scheduled by the
The impact of chronic cough is significant and often leads to a decline in patients' social, physical, and psychological quality of life. In IPF, chronic cough may lead to worsening disease and may be associated with a higher risk of progression, death, or need for lung transplant. There are no approved therapies for the treatment of chronic cough in IPF and current treatment options provide minimal benefit to patients. Chronic cough affects up to
Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority.
For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials, expectations regarding Trevi's uses and sufficiency of capital, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries,, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2024 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact
Katie Barrett
Trevi Therapeutics, Inc.
203-304-2499
k.barrett@trevitherapeutics.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
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SOURCE Trevi Therapeutics, Inc.
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