The event will feature presentations from
experts Dr. Peter Dicpinigaitis, MD,
and Dr. Brian Kim, MD, MTR
Virtual event to be held on Monday, September 19th from
10 AM – 12:30
PM ET
NEW
HAVEN, Conn., Aug. 30,
2022 /PRNewswire/ -- Trevi Therapeutics, Inc.
(Nasdaq: TRVI), a clinical-stage biopharmaceutical company
developing an investigational therapy Haduvio™ (oral
nalbuphine ER) for the treatment of prurigo nodularis and chronic
cough in adults with idiopathic pulmonary fibrosis (IPF), today
announced that it will host a virtual R&D Day on Monday, September 19, 2022, from 10:00 AM to 12:30 PM Eastern Time.
Trevi's leadership team to host R&D Day
alongside key opinion leaders in cough and itch
The event will feature presentations from key opinion leaders on
the current treatment landscape and unmet medical need in patients
with chronic cough and prurigo nodularis. Speakers include Dr.
Peter Dicpinigaitis, MD, Professor
of Medicine, Albert Einstein College
of Medicine, Division of Critical Care Medicine, Montefiore Medical
Center, Director, Montefiore Cough Center and Editor-in-Chief,
LUNG, and Dr. Brian Kim, MD, MTR,
Sol and Clara Kest Professor, Vice Chair of Research, and Director
of the Mark Lebwohl Center for Neuroinflammation and Sensation.
They will be joined by Trevi's leadership team who will provide an
update on the Company's development plans for Haduvio, followed by
a live Q&A session. To register for the event please click
here.
Interim data from the Phase 2 Cough and Nalbuphine (CANAL) trial
and topline data from Trevi's Phase 2b/3 Pruritus Relief through Itch-Scratch
Modulation (PRISM) trial both demonstrated statistically
significant results with Haduvio and no new safety signals were
identified. Haduvio has the potential to be a first-in-class oral
therapy for both chronic cough in IPF as well as prurigo nodularis
and the dual central and peripheral mechanism of action provides a
differentiated approach to these refractory conditions.
A live webcast, including audio, video, and presentation slides,
will be accessible on ir.trevitherapeutics.com at the time of the
meeting. Interested parties unable to watch the live webcast will
be able to view and listen to an archived copy of the webcast,
including the slides, which will be available on
ir.trevitherapeutics.com.
About Trevi Therapeutics, Inc.
Trevi
Therapeutics, Inc. is a clinical-stage biopharmaceutical
company focused on the development and commercialization of the
investigational therapy Haduvio for the treatment of prurigo
nodularis and chronic cough in adults with idiopathic pulmonary
fibrosis. These conditions share a common pathophysiology that is
mediated through opioid receptors in the central and peripheral
nervous systems.
Founded in 2011, Trevi Therapeutics is headquartered
in New Haven, CT.
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
known to be critical mediators of itch, cough and certain movement
disorders. 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. Nalbuphine ER has been granted Fast
Track designation by the FDA for the treatment of itch in patients
with prurigo nodularis. 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 the expected timing of reporting top-line data
from the full set of subjects' data from Trevi's Phase 2 CANAL
trial of Haduvio in chronic cough in adults with IPF ; Trevi's
business plans and objectives, including future plans or
expectations for Trevi's product candidates; 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,
including with respect to the timing of reporting top-line data
from the Phase 2 CANAL trial; uncertainties regarding Trevi's
ability to execute on its strategy; the risk that positive interim
or top-line results from a clinical trial may not necessarily be
predictive of the results of the completed trial or other future or
ongoing clinical trials; potential regulatory developments in
the United States and foreign
countries; uncertainties regarding fast track designation and the
effect such status could have on the regulatory review or approval
process; uncertainties inherent in estimating Trevi's cash runway,
future expenses and other financial results, including Trevi's
ability to fund future operations; 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 June 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.