Trevi Therapeutics Maintains Sample Size in Key IPF Trial

Trevi Therapeutics Reaffirms Sample Size in Phase 2b CORAL Trial

Trevi Therapeutics, Inc. (NASDAQ: TRVI), a biopharmaceutical company with a focus on investigational therapies, has exciting news for those following its Phase 2b CORAL trial. The trial is evaluating the efficacy of Haduvio™ (oral nalbuphine ER) in patients suffering from idiopathic pulmonary fibrosis (IPF) with chronic cough. Recently, the independent Data Monitoring Committee reviewed the sample size and confirmed that it will remain at 160, an affirmation of the trial's design and expectations.

Current Enrollment Progress and Timeline

The CORAL trial has now reached 75% of its target enrollment, which brings it closer to providing critical data on the effectiveness of Haduvio in treating chronic cough in IPF patients. With topline results anticipated in the first half of 2025, this milestone reinforces Trevi Therapeutics' commitment to addressing an urgent need in the IPF community where no approved therapies currently exist.

Understanding the Sample Size Re-estimation (SSRE)

The recent outcome of the sample size review, known as the SSRE, occurred after half of the initial enrollment target, approximately 80 patients, had successfully completed their six weeks of treatment. The positive analysis ensures that the study can maintain its key parameters, including an 80% power for efficacy assessment. The alternative strategies considered were to increase sample size or declare the trial futile, showcasing the robustness of the current approach.

Reactions from Trevi's Leadership

Jennifer Good, President and CEO of Trevi Therapeutics, expressed her satisfaction with the outcomes of the SSRE, stating, "We are pleased that the SSRE outcome supports the continued execution of the CORAL trial with the total number of patients as originally planned. This positive outcome reassures us of the assumptions that underpin our trial's design, reinforcing our belief in Haduvio's potential. We view this as a significant validation of the efficacy observed in the earlier Phase 2a CANAL trial involving IPF cough patients, emphasizing the urgent need for treatment options in this area."

Details of the CORAL Trial Design

The CORAL trial is a rigorously designed study that is double-blind, randomized, and placebo-controlled. Participants will be assigned to receive one of three doses of Haduvio (27mg, 54mg, and the highest 108mg twice daily) or a placebo for a total of six weeks. The initial two weeks will involve titration to the target dose, followed by four weeks of consistent dosing. The primary endpoint is the relative change in cough frequency over the treatment duration.

About Haduvio and Its Significance

Haduvio is an innovative investigational therapy that acts on both central and peripheral nervous systems to alleviate cough symptoms. Given that chronic cough is prevalent in over 85% of IPF patients, with significant effects on their quality of life, the need for effective therapies has never been more critical. Haduvio emerges as a promising potential solution, targeting a debilitating condition that presently lacks adequate treatment options.

Impact of Chronic Cough on IPF Patients

Chronic cough is more than just a symptom for patients with IPF; it significantly affects their day-to-day life, leading to complications such as social withdrawal and psychological distress. With approximately 140,000 individuals in the U.S. diagnosed with IPF, addressing chronic cough can lead to improved patient outcomes and quality of life. The impact of this condition is profound, with some patients experiencing upwards of 1,500 cough episodes in a single day. Such statistics underline the urgency for effective treatments.

Broader Implications of Refractory Chronic Cough

Refractory chronic cough, affecting an estimated 2-3 million adults in the U.S., results from overactive cough reflexes, creating a challenging situation for patients. The consequences extend from personal discomfort to severe social and occupational disruptions. Trevi Therapeutics is not only focused on treating IPF chronic cough but is also exploring Haduvio for the management of refractory chronic cough, which underscores its mission to innovate in this area.

Next Steps for Trevi Therapeutics

Looking ahead, Trevi Therapeutics is committed to continuing the CORAL trial as planned while assessing the progress and outcomes of the ongoing treatment study. The focus remains on generating substantial evidence that could position Haduvio as a new treatment option for patients who currently have few to no alternatives.

Investor and Media Contacts

For inquiries regarding Trevi Therapeutics, interested parties can connect with Katie Barrett at 203-304-2499 for investor-related questions. Media representatives can reach out to Rosalia Scampoli at 914-815-1465 for communication needs.

Frequently Asked Questions

What is the purpose of the CORAL trial?

The CORAL trial aims to evaluate the effectiveness of Haduvio in treating chronic cough in patients with idiopathic pulmonary fibrosis.

What was the outcome of the sample size re-estimation?

The independent analysis confirmed that the sample size will remain at 160 patients, supporting the trial's initial design.

When are the topline results expected?

Topline results from the CORAL trial are anticipated in the first half of 2025.

What is Haduvio used for?

Haduvio is being developed as a treatment for chronic cough in patients with idiopathic pulmonary fibrosis and for refractory chronic cough.

Why is chronic cough a concern for IPF patients?

Chronic cough is highly prevalent in IPF patients, affecting their quality of life and potentially leading to worsened health outcomes.

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