David Clark,
MD, MRCP, will lead the continued development of Haduvio™
NEW
HAVEN, Conn., Nov. 14,
2022 /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 adults with
idiopathic pulmonary fibrosis (IPF) and other chronic cough
indications, and for the treatment of prurigo nodularis, today
announced the appointment of David
Clark, MD, MRCP, as Chief Medical Officer (CMO). Dr. Clark
will join Trevi's executive team and be responsible for the
strategy and execution of Haduvio's clinical programs.
"I am pleased to welcome David to our executive leadership
team," said Jennifer Good, President
and CEO of Trevi Therapeutics. "David brings his respiratory
background to Trevi through his medical training and drug
development experience. In addition, we believe his strong track
record as a biotech CMO and successful delivery of Phase 3 programs
will enable David to play a key role as we progress the development
of Haduvio in our targeted indications."
Dr. Clark joins Trevi with over 25 years of global clinical
development experience in big pharma and biotech. Most recently,
Dr. Clark served as Chief Medical Officer at Allena
Pharmaceuticals, leading the Company's clinical development,
regulatory and medical affairs teams. Prior to that, he served as
Chief Medical Officer for various companies, including Aldeyra
Therapeutics, Wilson Therapeutics, and NormOxys. As Chief Medical
Officer, Dr. Clark has strategized and supported teams from
clinical translation through Phase 3. He has also held senior
leadership positions at TransTech Pharma, Pfizer, SmithKline
Beecham, and GlaxoSmithKline. Dr. Clark holds a Bachelor of
Medicine and Surgery (MD) from the University
of Edinburgh Medical School, and a Membership of the Royal
College of Physicians (MRCP). Dr. Clark also completed a research
fellowship in respiratory medicine in the United Kingdom.
"Idiopathic pulmonary fibrosis is a very debilitating disease
for patients in which cough plays a central role," said Dr. Clark.
"I was impressed with the results from the Phase 2 CANAL trial and
believe Haduvio's centrally acting mechanism has the potential to
significantly impact this disease. I look forward to progressing
Haduvio through development for the treatment of chronic cough in
adults with IPF, as well as initiating development work in other
serious chronic cough conditions."
Dr. Thomas Sciascia, MD, the
co-founder of Trevi Therapeutics, previously served as Trevi's
Chief Medical Officer and will be transitioning to Chief Science
Officer. His background as a board-certified neurologist and his
experience with the development of Haduvio to date provides a deep
understanding of Haduvio's mechanism. Dr. Sciascia's extensive
knowledge of Haduvio will be applied to strengthen the continued
exploration of Haduvio in serious chronic cough conditions.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical
company developing the investigational oral therapy Haduvio™
(nalbuphine ER) for the treatment of chronic cough in adults with
idiopathic pulmonary fibrosis (IPF) and other chronic cough
indications, and for the treatment of prurigo nodularis. The
Company has successfully completed a Phase 2 CANAL trial of Haduvio
for the treatment of chronic cough in adults with idiopathic
pulmonary fibrosis (IPF). Based on this positive data, Trevi plans
to focus future clinical development on chronic cough conditions,
including IPF, refractory chronic cough, and interstitial lung
diseases (ILDs).
For more information, visit www.TreviTherapeutics.com and follow
the Company on Twitter and LinkedIn.
About Haduvio
Haduvio, an investigational therapy, is an oral extended-release
(ER) formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid
receptor agonist and µ-opioid receptor antagonist that has been
approved and marketed as an injectable for pain indications for
more than 20 years in the United States and Europe.
The ĸ- and µ-opioid receptors are centrally and peripherally active
and known to be critical mediators of cough and itch. Nalbuphine's
mechanism of action may also mitigate the risk of abuse associated
with µ-opioid agonists because it antagonizes, or blocks, µ-opioid
receptors. Parenteral nalbuphine is not currently scheduled as a
controlled substance by the DEA in the United States or
by regulatory authorities in most
of Europe. Trevi intends to propose Haduvio as the
trade name for nalbuphine ER. Its safety and efficacy have not been
evaluated by any regulatory authority.
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 with respect to future clinical
trials, 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 future 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; uncertainties inherent in estimating Trevi's
cash runway, future expenses and other financial results, including
Trevi's ability to fund future operations, including clinical
trials; uncertainties regarding the scope, timing and severity of
the COVID-19 pandemic, the impact of the COVID-19 pandemic on
Trevi's clinical operations and actions taken in response to the
pandemic; as well as other risks and uncertainties set forth in the
quarterly report on Form 10-Q for the quarter ended September
30, 2022 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 McManus
Trevi Therapeutics,
Inc.
203-304-2499
k.mcmanus@trevitherapeutics.com
Media Contact
Rosalia
Scampoli
914-815-1465
rscampoli@marketcompr.com
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SOURCE Trevi Therapeutics, Inc.