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Trevi Therapeutics Completes Enrollment for Phase 2b CORAL Trial of Haduvio in IPF Patients

The clinical-stage biopharmaceutical firm, Trevi Therapeutics, Inc., has recently announced a major milestone in its research efforts. The company has completed patient enrollment for its Phase 2b CORAL trial, which focuses on testing the investigational therapy Haduvio™ (oral nalbuphine ER) specifically designed for chronic cough linked to idiopathic pulmonary fibrosis (IPF). With preliminary results anticipated by mid-2025, the study aims to fill a critical gap in treatment options for patients suffering from chronic cough in this particular context.

Chronic cough is a prevalent issue among those diagnosed with IPF, and it can drastically diminish their quality of life. According to research, nearly 85% of IPF patients experience chronic cough, often leading them to cough up to 1,500 times a day. This incessant coughing can exacerbate their overall health condition, heighten the risk of disease progression, and result in a greater need for lung transplant. Given the harmful effects, current treatment options available off-label are largely ineffective, thereby creating a significant unmet need within this patient population.

James Cassella, the Chief Development Officer at Trevi Therapeutics, commented on the completion of enrollment, emphasizing its significance. He noted that the trial's findings would be crucial in determining the appropriate dosages for Haduvio moving forward into Phase 3 of their program. This leads to hopes that effective treatment can be developed for those grappling with the persistent and distressing cough associated with IPF.

The CORAL trial itself is structured as a double-blind, randomized, placebo-controlled study, wherein approximately 160 patients have been divided among three dosage levels: 27mg, 54mg, and 108mg, all administered twice daily. Following an initial two-week titration period, participants will experience a four-week period where they’ll receive fixed doses of either Haduvio or a placebo. Evaluating the primary efficacy endpoint involves measuring the relative change in cough frequency over 24 hours, assessed via an objective cough monitor, at the end of Week 6 compared to the baseline measure. Additionally, the trial will delve into secondary endpoints including patient-reported outcomes pertaining to their cough.

The insight gathered from this trial will be vital, particularly since there are currently no approved treatments for chronic cough related to IPF in the United States, and other alternatives have shown limited efficacy. As part of its ongoing commitment to clinical innovation, Trevi Therapeutics has positioned Haduvio as a promising option, acting both centrally and peripherally on the cough reflex arc as a kappa agonist and a mu antagonist (KAMA).

Approximately 140,000 individuals in the United States are contending with IPF, and among them, the consequences of chronic cough are profound. It leads not only to physical distress but also affects social interactions and emotional well-being, increasing the burden on both patients and their families.

Haduvio, which Trevi plans to propose as the commercial name for oral nalbuphine ER, remains unregulated by the U.S. Drug Enforcement Agency, reflecting its unique position in tackling chronic cough without the restrictions associated with more traditional opioid treatments. This could afford an additional layer of accessibility for those afflicted, as the company strives to address one of the more overlooked but challenging aspects of living with IPF.

For more details about Trevi Therapeutics and its ongoing projects, you can visit their official website or follow them on social media channels like X (formerly Twitter) and LinkedIn. As Trevi looks ahead, the expectations for reporting topline results later this year continues to build, in hopes of paving the way for effective therapeutic alternatives for patients burdened by unmanaged chronic cough.