Trevi Therapeutics Confirms Phase 2b Trial Sample Size for Chronic Cough Treatment in IPF Patients

Trevi Therapeutics Confirms Sample Size for CORAL Trial

Trevi Therapeutics, Inc. (Nasdaq: TRVI) recently reported a significant update regarding its Phase 2b CORAL trial, which evaluates the investigational therapy Haduvio™ for addressing chronic cough in patients with idiopathic pulmonary fibrosis (IPF). The trial aims to provide effective treatment options for patients who currently have no approved therapies available.

The positive outcome of the planned sample size re-estimation (SSRE) confirmed that the trial will continue with the original sample size of 160 participants, as stated by independent data monitoring statisticians. Currently, the trial has successfully enrolled 75% of the targeted participants, and results are predicted to be released in the first half of 2025.

The SSRE analysis was conducted after 50% of the intended trial subjects completed six weeks of treatment at the highest dosage of Haduvio (108mg taken twice daily). This analysis highlighted the necessity to maintain the pre-specified conditional power of 80% or more, supporting the continuation of the trial as initially planned.

Jennifer Good, the President and CEO of Trevi Therapeutics, expressed satisfaction with the SSRE outcome, affirming the trial's design and its expectations for the efficacy of Haduvio, which was observed in previous studies like Phase 2a CANAL, focused on IPF cough patients. Good explained that the results bolster the company's belief in Haduvio's potential as a leading therapy for chronic cough associated with IPF, where such treatment options are glaringly absent.

Overview of the CORAL Trial

The CORAL trial is a double-blind, randomized, placebo-controlled study, exploring three dosing levels of Haduvio (27mg, 54mg, and 108mg twice daily) compared to a placebo in individuals suffering from chronic cough due to IPF. This study encompasses approximately 160 participants who will be randomly assigned to receive either Haduvio or placebo for a six-week period. The trial's design includes an initial two-week titration phase before moving to a fixed dosing regimen for the remaining four weeks.

The primary focus of efficacy is on the relative change in 24-hour cough frequency from baseline to the end of week six, measured through an objective cough monitoring method using VitaloJAK®. Additionally, the trial intends to examine secondary endpoints that reflect patient-reported outcomes regarding their coughing experience.

Understanding the Need for Haduvio

Chronic cough notably impacts up to 85% of the IPF patient cohort, with consequences manifesting in symptoms such as persistent coughing—often up to 1,500 times a day—and the resulting complications which can lead to a worsening of overall health, including possible lung transplants. Presently, around 140,000 patients in the U.S. face this challenge.

Clinical studies have indicated that chronic cough significantly deteriorates patients' social, psychological, and physical quality of life. Furthermore, refractory chronic cough afflicts approximately 2-3 million adults in the U.S. It is characterized by a hypersensitive cough reflex and can lead to various complications, such as sleep disturbances and social embarrassment.

Haduvio represents a promising therapeutic option as it engages opioid receptors that are integral in coughing regulation. This investigational medication targets both central and peripheral components of the cough reflex arc and has the potential to alleviate symptoms in individuals suffering from such chronic conditions.

Future Outlook

Looking forward, Trevi Therapeutics plans to advance Haduvio as a trade name for oral nalbuphine extended-release. However, it's crucial to note that the safety and efficacy of this compound are currently under evaluation and have not yet received assessment from regulatory agencies.

As the company continues progressing with the CORAL trial, Trevi remains committed to unraveling the therapeutic potential of Haduvio and ultimately providing much-needed relief to patients suffering from chronic cough associated with IPF. For continual updates, you can visit Trevi Therapeutics' official website and follow them on X (formerly Twitter) and LinkedIn.