Trevi Therapeutics Completes Enrollment for Phase 2a RIVER Trial in Refractory Chronic Cough

Rhea-AI Summary

Trevi Therapeutics (Nasdaq: TRVI) has completed enrollment for its Phase 2a RIVER trial, evaluating Haduvio™ (oral nalbuphine ER) for refractory chronic cough (RCC). The company expects to report topline results in Q1 2025. The trial is a randomized, double-blind, placebo-controlled study conducted in the UK and Canada, designed to assess the efficacy, safety, and tolerability of Haduvio in RCC patients.

The primary endpoint is the mean change in 24-hour cough frequency, measured by an objective cough monitor. The study includes two subgroups based on cough frequency: moderate (10-19 coughs/hour) and high (≥20 coughs/hour). Secondary endpoints include patient-reported outcome measures for cough frequency and severity. Approximately 60 adult patients were enrolled in the trial.

Positive

• Completed enrollment for Phase 2a RIVER trial in refractory chronic cough
• Addressing a large unmet need with approximately 2-3 million adults affected by RCC in the U.S.
• Building on positive results from previous chronic cough studies in IPF

Negative

• Topline results not expected until Q1 2025, indicating a long wait for data

Insights

Clinical Research Analyst

The completion of enrollment for Trevi Therapeutics' Phase 2a RIVER trial in refractory chronic cough (RCC) is a significant milestone. This study targets a substantial unmet medical need, with 2-3 million adults in the U.S. affected by RCC and no approved treatments available.

Key points to consider:

• The trial design is robust, featuring a randomized, double-blind, placebo-controlled, crossover study.
• The primary endpoint of mean change in 24-hour cough frequency is objectively measurable, which strengthens the potential validity of results.
• Stratification into moderate and high cough frequency subgroups may provide valuable insights into treatment efficacy across different patient populations.
• Secondary endpoints including patient-reported outcomes will offer a more comprehensive view of the treatment's impact.

While the topline results expected in Q1 2025 are still over a year away, this news indicates the study is progressing as planned. Investors should monitor for any interim updates or potential catalysts that could impact the company's valuation before the final data readout.

Financial Analyst

From a financial perspective, the completion of enrollment in the RIVER trial is a positive development for Trevi Therapeutics, but its immediate impact on the company's financials is Key considerations:

• With a market cap of $226,486,781, Trevi is a small-cap biopharmaceutical company, making it sensitive to clinical trial progress.
• The RCC market represents a significant opportunity, potentially translating to substantial revenue if Haduvio proves effective and gains approval.
• However, investors should be cautious as the topline results are not expected until Q1 2025, which is a considerable wait in biotech terms.
• Cash runway will be crucial; investors should assess if Trevi has sufficient funds to reach this data readout without dilutive financing.
• The company's diversified approach, studying Haduvio in both RCC and IPF chronic cough, may provide some risk mitigation.

While this news is incrementally positive, it's unlikely to significantly move the stock price in the short term. Long-term investors should view this as a step towards potential value creation, contingent on positive trial results.

Topline results are expected in the first quarter of 2025

NEW HAVEN, Conn., Oct. 21, 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 it has completed enrollment in its Phase 2a trial for the treatment of RCC ("RIVER") and expects to report topline data in the first quarter of 2025.

"We are happy to have completed enrollment for our Phase 2a RIVER trial for the treatment of RCC," said Jennifer Good, President and CEO of Trevi Therapeutics. "RCC impacts approximately 2-3 million adults in the U.S. and with no approved treatment options, there is a large unmet need for new therapies that address cough hypersensitivity. We look forward to reporting the topline results for RIVER early next year and building on the positive results we have seen in studying chronic cough in IPF."

Phase 2a Trial Design: Refractory Chronic Cough Improvement Via Nal ER (RIVER)
The Phase 2a RIVER trial is a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability and dosing of Haduvio for the treatment of RCC. The trial is being conducted at multiple sites in the United Kingdom and Canada. The primary endpoint of the trial is a mean change in 24-hour cough frequency in the overall population as determined using an objective cough monitor. Based on the screening results, the study will enroll patients into one of two subgroups: 10-19 coughs/hour (moderate 24-hour cough frequency) and ≥20 coughs/hour (high 24-hour cough frequency). The trial will also explore secondary endpoints, including patient-reported outcome measures for cough frequency and severity. The trial was designed to enroll approximately 60 adult patients.

About Refractory Chronic Cough (RCC)
Refractory chronic cough has no approved therapies in the U.S. and is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, and upper airway cough syndrome or post-nasal drip) or where no underlying condition exists. RCC affects ~2-3 million patients in the U.S. and is caused by cough reflex hypersensitivity in both the central and peripheral nerves. It is highly disruptive and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burdens for patients and those around them.

About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release (ER)) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), which are opioid receptors that play a key role in controlling cough hypersensitivity. 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.

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 expectation of reporting topline data from Trevi's Phase 2a RIVER trial in the first quarter of 2025. Risks that contribute to the uncertain nature of the forward-looking statements include uncertainties regarding the success and timing of Trevi's product candidate development activities, including its ongoing clinical trials, uncertainties regarding Trevi's ability to execute on its strategy, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 30, 2024 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 Barrett
Trevi Therapeutics, Inc.
203-304-2499
k.barrett@trevitherapeutics.com

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

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SOURCE Trevi Therapeutics, Inc.

FAQ

What is the primary endpoint of Trevi Therapeutics' RIVER trial for TRVI?

The primary endpoint of the RIVER trial is the mean change in 24-hour cough frequency in the overall population, as determined using an objective cough monitor.

When does Trevi Therapeutics (TRVI) expect to report topline results for the RIVER trial?

Trevi Therapeutics expects to report topline results for the RIVER trial in the first quarter of 2025.

How many patients were enrolled in Trevi Therapeutics' Phase 2a RIVER trial for TRVI?

The Phase 2a RIVER trial was designed to enroll approximately 60 adult patients with refractory chronic cough.

What is the investigational therapy being tested in Trevi Therapeutics' RIVER trial for TRVI?

The investigational therapy being tested in the RIVER trial is Haduvio™ (oral nalbuphine ER) for the treatment of refractory chronic cough.