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Trevi Therapeutics Announces Additional Analyses of Cough Relief Time from Ph2a CANAL Trial Accepted for Oral Presentation at CHEST 2024

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Trevi Therapeutics (Nasdaq: TRVI) announced that additional analyses of cough relief time from their Phase 2a CANAL trial have been accepted for oral presentation at CHEST 2024. The presentation, by Professor Alyn Morice, will cover post-hoc analyses of 38 IPF patients who completed at least one treatment period. Results showed:

1. Significant increase in relief-of-cough time
2. Reduced cough time
3. Reduced cough intensity

These effects were observed in IPF patients treated with nalbuphine ER compared to placebo. The safety profile was consistent with previous trials. Common adverse events included nausea, dizziness, and anxiety. The presentation is scheduled for October 8, 2024, at the CHEST Annual Meeting in Boston.

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Positive

  • Acceptance of additional analyses for oral presentation at CHEST 2024, a significant medical conference
  • Positive results showing significant increase in relief-of-cough time and reduced cough time and intensity in IPF patients
  • Safety profile consistent with previous trials, indicating no new safety concerns

Negative

  • Reported adverse events including nausea, dizziness, anxiety, and other side effects
  • Results based on post-hoc analyses, which may be considered less robust than pre-planned analyses

News Market Reaction – TRVI

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+2.27% News Effect

On the day this news was published, TRVI gained 2.27%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Professor Alyn Morice will present an analysis of cough relief in patients with idiopathic pulmonary fibrosis who were treated with nalbuphine ER

NEW HAVEN, Conn., Sept. 26, 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 that data from the Phase 2a CANAL trial will be presented at CHEST 2024 held in Boston, Massachusetts from October 6-9.

The presentation by Professor Alyn Morice, Head of Respiratory Medicine at HYMS and leader of the Hull Cough Clinic, will take place on October 8th and include cough data from 38 IPF patients who completed at least 1 treatment period of the CANAL trial. The presentation covers post-hoc analyses of patients' relief-of-cough duration (any ≥15-minute cough-free period), cough time (total observation time – relief time), and cough intensity (number of coughs during coughing time). The results demonstrated a significant increase in relief-of-cough time, reduced cough time, and reduced cough intensity in IPF patients with nalbuphine ER compared with placebo. The safety results of the trial were generally consistent with the known safety profile of nalbuphine ER from previous trials. The most frequently reported treatment-emergent adverse events with nalbuphine ER treatment were nausea, dizziness, anxiety, constipation, vomiting, dry mouth, headache, somnolence, dyspnea, decreased appetite, fatigue and lethargy.

CHEST 2024
October 6 – 9, 2024, Boston, Massachusetts
Session: ILD Abstracts Potpourri
Presentation Date & Time: October 8, 1:51 p.m. – 1:55 p.m. EDT
Location: Convention Center Exhibit Hall, Area 2B
Abstract Accepted for Oral Presentation: Analysis of Relief-Of-Cough in Patients with Idiopathic Pulmonary Fibrosis Treated with Oral Nalbuphine Extended Release
Presenter: Professor Alyn Morice is Head of Respiratory Medicine at HYMS and leader of the Hull Cough Clinic. Registration details: CHEST Annual Meeting 

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 an extended-release (ER) 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.

Investor Contact
Katie McManus
Trevi Therapeutics, Inc.
203-304-2499
k.mcmanus@trevitherapeutics.com 

Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/trevi-therapeutics-announces-additional-analyses-of-cough-relief-time-from-ph2a-canal-trial-accepted-for-oral-presentation-at-chest-2024-302259142.html

SOURCE Trevi Therapeutics, Inc.

FAQ

What are the key findings from Trevi Therapeutics' (TRVI) CANAL trial presented at CHEST 2024?

The CANAL trial showed that nalbuphine ER significantly increased relief-of-cough time, reduced cough time, and reduced cough intensity in IPF patients compared to placebo. These findings will be presented at CHEST 2024 on October 8, 2024.

When and where will Trevi Therapeutics (TRVI) present their CANAL trial results?

Trevi Therapeutics will present the CANAL trial results at CHEST 2024 in Boston, Massachusetts. The presentation is scheduled for October 8, 2024, at 1:51 p.m. EDT in the Convention Center Exhibit Hall, Area 2B.

What were the common side effects reported in Trevi Therapeutics' (TRVI) nalbuphine ER trial?

The most frequently reported side effects in the nalbuphine ER trial were nausea, dizziness, anxiety, constipation, vomiting, dry mouth, headache, somnolence, dyspnea, decreased appetite, fatigue, and lethargy.

How many patients were included in the analysis of Trevi Therapeutics' (TRVI) CANAL trial?

The analysis included data from 38 IPF patients who completed at least one treatment period of the CANAL trial.
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