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Trevi Therapeutics (TRVI) Reports Positive Data from Full Set of Subjects in CANAL Phase 2 Haduvio Trial

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Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing an investigational therapy, Haduvio™ (oral nalbuphine ER), for the treatment of chronic cough in adults with idiopathic pulmonary fibrosis (IPF) and nodular prurigo ( PN), today announced positive results from the full set of its Phase 2 subjects VSugh An/a NALbuphine (CANAL) from Haduvio for the treatment of chronic cough in IPF. Dr. William Forbes will present the data at the Society’s conference Virtual R&D day today, Monday, September 19 from 10:00 a.m. to 11:45 a.m. ET.

Following the statistically significant efficacy results of the Interim analysis of the CANAL trial (N=26) conducted in February 2022, the company concluded enrollment in early March 2022 and allowed enrolled subjects to complete the trial. Primary data from the full set of subjects (N=38) of the Phase 2 CANAL trial were statistically significant for the primary endpoint of the trial and showed a 52.5% change from baseline. placebo (p

“We are pleased to announce the positive results from all subjects in the CANAL trial, which are consistent with the previously announced interim analysis and which further demonstrated that Haduvio has the potential to reduce cough in patients with of REIT,” said Jennifer Good, President. and CEO of Trevi Therapeutics. “We analyzed the change in cough frequency over 24 hours as well as cough frequency during the day and observed consistent reductions for both measures. There are no approved treatments for chronic cough in these patients, and we are excited to continue our development in this indication and look forward to commencing our next clinical trial for these patients in the first half of 2023. We would like to thank the CANAL trial participants and investigators for their contribution to this research as we look to improve the quality of life of IPF patients.

“It is very promising to see such a significant reduction in chronic cough in IPF patients with nalbuphine ER,” said Peter Dicpinigaitis, MD, professor of medicine at Albert Einstein College of Medicine and director of the Montefiore Cough Center. , At New York. . “There is a great unmet need for chronic cough therapies and I believe there is great potential to improve the lives of patients with an oral therapy with a central mechanism of action.”

Analysis of CANAL primary efficacy parameter (N = 38):

Complete analysis package

Daytime Cough Frequency at End of Treatment Period Compared to Baseline Study Values

Nalbuphine ER BID


Placebo BID


Placebo-adjusted change

52.5% (p

The full analysis set includes subjects who completed at least 1 treatment period.

Additional efficacy analyses:

  • Haduvio subjects had a 76.1% reduction in cough frequency over 24 hours compared to 25.3% of placebo subjects, a placebo-adjusted change of 50.8% (p
  • In a post-hoc analysis, 97% of Haduvio subjects showed at least a 30% reduction in cough frequency over 24 hours compared to 35% of placebo subjects, signifying a clinically meaningful reduction in cough frequency. cough (p.
  • Subjects on Haduvio experienced statistically significant improvement as measured by their patient-reported outcomes compared to placebo over the 3-week treatment period in EXACT2: cough frequency score (p=0.001) and scale numerical rating of cough severity (p = 0.0001).
  • Based on the Clinical Global Impression of Change assessment measuring clinicians’ opinion of change since the start of the trial, 62% of Haduvio subjects improved from baseline, compared to 19% of subjects placebo (p=0.01).

Safety and tolerance results:

The trial’s safety results were generally consistent with the known safety profile of Haduvio in previous trials. Two serious adverse events were reported during the trial, none of which were considered by the investigator to be related to the treatment. The most common adverse events observed during the trial were nausea, fatigue, constipation, dizziness, somnolence, vomiting, headache, anxiety and depression.

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Virtual R&D Day Details

The Virtual R&D Day event will include presentations from key opinion leaders on the current treatment landscape and unmet medical needs in patients with chronic cough and prurigo nodularis. Trevi’s management team will also present data from the CANAL and PRISM trials and provide an update on the company’s development plans for Haduvio. A live webcast, including audio, video and presentation slides, will be accessible on at the time of the meeting. Interested parties who cannot 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 at

About chronic cough in idiopathic pulmonary fibrosis

IPF is a serious end-of-life disease in which cough is one of the most prominent symptoms. It is estimated that there are 140,000 patients with IPF in the United States and more than one million patients outside the United States, where up to 85% of these patients suffer from chronic cough. There is no approved therapy for the treatment of chronic cough in IPF, and the cough is often refractory to antitussive therapy. Patients with chronic cough in IPF may cough up to 1,500 times a day, which leads to increased feelings of anxiety as it induces shortness of breath. Cough attacks or episodes lead to significant fatigue, air hunger, peripheral oxygen desaturation and some patients also suffer from cough-related urinary incontinence. The social impact of chronic cough in IPF further aggravates limited exercise capacity, reduced walking distance, and the need to use supplemental oxygen. Chronic cough in IPF may be an early clinical marker of disease activity, identify patients at high risk of progression, predict time to death or lung transplantation, and may also contribute to better activation of mechanisms profibrotic and disease aggravation in IPF.


Stage 2 VSugh An/a NALbuphine (CANAL) was a double-blind, randomized, placebo-controlled, 2-treatment, 2-period crossover efficacy and safety study of nalbuphine ER for chronic cough in patients with IPF that proceeded United Kingdom. The study consisted of 2 treatment periods of 3 weeks, with a washout period of 2 weeks after each treatment period. The primary efficacy endpoint was to assess the effect of nalbuphine ER tablets on mean daytime cough frequency at day 22 compared to placebo, as measured by an objective cough monitor. More information about the CANAL trial is available at NCT04030026

About Trevi Therapeutics, Inc.

Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing the investigational therapy Haduvio for the treatment of chronic cough in adults with idiopathic pulmonary fibrosis and prurigo nodularis. These conditions share a common pathophysiology that is mediated by 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 ß-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for over 20 years in the United States and Europe. The ĸ and µ opioid receptors are known to be essential mediators of cough and itch. Nalbuphine’s mechanism of action may also mitigate the abuse potential associated with µ-opioid agonists, as it antagonizes or blocks µ-opioid receptors. Trevi intends to offer Haduvio as a trade name for nalbuphine ER. Nalbuphine ER has received Fast Track designation from the FDA for the treatment of itching in patients with prurigo nodularis. Its safety and effectiveness have not been evaluated by any regulatory authority.

Forward-looking statements

Statements 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 the results actual may differ materially from those expressed. or implied by such forward-looking statements. These statements include, but are not limited to, statements regarding Trevi’s business plans and objectives, including future plans or expectations for Trevi’s product candidates and plans regarding future clinical trials, and other statements containing the words “believes”, “anticipates”, “plans”, “expects” and similar expressions. Risks that contribute to the uncertain nature of forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi’s product candidate development activities and ongoing and planned clinical trials; uncertainties regarding Trevi’s ability to execute its strategy; uncertainties regarding the views of regulatory authorities regarding Trevi’s clinical trial data and the next steps in the development of Trevi’s product candidates in the United States and foreign countries; the uncertainties inherent in estimating Trevi’s cash flow, 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; and 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 these statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contact InvestorKatie McManus Trevi Therapeutics, Inc.203-304-2499[email protected]

Media ContactRosalia Scampoli914-815-1465[email protected]

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SOURCE Trevi Therapeutics, Inc.