Trevi Therapeutics, Inc., a clinical-stage biopharmaceutical company developing an investigational therapy Haduvio™ for the treatment of prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis, 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.
- 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.
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.
Company Codes: NASDAQ-NMS:TRVI
