NEW
HAVEN, Conn., Sept. 30,
2024 /PRNewswire/ -- Trevi Therapeutics,
Inc. (Nasdaq: TRVI), 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), today
announced the appointment of James V.
Cassella, Ph.D., as Chief Development Officer
(CDO).
"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 $576 million Company acquisition by Sun
Pharmaceutical Industries. Prior to joining Concert, Dr. Cassella
was Executive Vice President, Research and Development and Chief
Scientific Officer at Alexza Pharmaceuticals from 2004-2015, where
he was responsible for the US and European approval of the CNS
drug, Adasuve™. He held other various management positions,
including Senior Vice President of Clinical Research and
Development at Neurogen Corporation, an innovative CNS-focused
biotechnology company, and was an Assistant Professor of
Neuroscience at Oberlin College. Dr.
Cassella received a Ph.D. in Physiological Psychology from
Dartmouth College, completed a
postdoctoral fellowship in the Department of Psychiatry at the
Yale School of Medicine and received a
B.A. in Psychology from the University of New
Haven.
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 U.S. Drug
Enforcement Agency.
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 10% of the
adult population, and Haduvio's expansion into RCC has the
potential to reach patients suffering from moderate to severe
refractory chronic cough. There are also no approved therapies for
RCC in the U.S.
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.