Trevi Therapeutics Achieves Significant Milestone with Phase 2b Trial Data on Chronic Cough Treatment
Trevi Therapeutics, Inc. continues to make waves in the biopharmaceutical industry with the groundbreaking findings from its Phase 2b trial on chronic cough treatment. The recent publication in the Journal of the American Medical Association (JAMA) has drawn significant attention to their investigational therapy, oral nalbuphine ER. This therapy aims to alleviate chronic cough in patients suffering from idiopathic pulmonary fibrosis (IPF) and the results indicate a promising future for those afflicted by this debilitating condition.
The Phase 2b trial, known as the Cough Reduction in IPF with nalbuphine ER (CORAL), tested the effectiveness of nalbuphine ER across three different dosages: 27 mg, 54 mg, and 108 mg, administered twice daily over a period of six weeks. A total of 165 patients with chronic cough related to IPF participated in this double-blind, placebo-controlled study.
The primary metric for efficacy in this trial was the reduction in 24-hour cough frequency, meticulously recorded through objective monitoring systems. Remarkably, patients who received nalbuphine ER showed a statistically significant decline in their coughs, with over 60% attaining at least a 50% reduction by the end of the six-week period compared to baseline measurements. This result is a crucial milestone in demonstrating the potential impact of nalbuphine ER on patients' quality of life, as chronic coughing in IPF patients can reach overwhelming frequencies of up to 1,500 times a day.
James Cassella, PhD, the Chief Development Officer at Trevi Therapeutics, expressed enthusiasm about the findings, stating that the results validate the importance of addressing chronic coughs in IPF patients. He emphasized that a significant number of participants achieved remarkable improvements, indicating that nalbuphine ER could play a vital role in managing symptoms.
Moreover, Dr. Philip Molyneaux, a Professor of Pulmonary Medicine at the Royal Brompton Hospital, highlighted the persistent challenges chronic cough presents for his patients with IPF. The consistency observed between patient-reported outcomes and objective data was particularly gratifying, underscoring that patients felt genuine relief alongside measured improvements in cough frequency.
The safety assessments conducted during the CORAL trial largely aligned with the previously established profile of nalbuphine ER. Discontinuation rates due to adverse events were comparable between the treatment and placebo groups, standing at 5.6% and 5.0%, respectively. The trial reported a spectrum of adverse events, with nausea, dizziness, and fatigue among the most common. Even serious adverse events were notably fewer in the nalbuphine ER group as opposed to the placebo group, an encouraging sign that the treatment was well-tolerated.
The significance of addressing chronic cough in patients with IPF cannot be overstated. Currently, with around 150,000 individuals in the U.S. diagnosed with IPF, the need for FDA-approved treatments targeting chronic cough remains unmet. The burden of symptoms can severely affect patients' daily lives, resulting in heightened morbidity and negatively impacting their overall well-being.
With promising data from the CORAL trial, Trevi Therapeutics is set to advance its efforts in developing nalbuphine ER, now branded as Haduvio™, which has shown efficacy in addressing chronic cough symptoms both in IPF and non-IPF related conditions. Trevi is committed to further studies to validate these findings and potentially seek regulatory approvals, heralding a hopeful future for countless individuals suffering from chronic cough.
For ongoing updates and more information about Trevi Therapeutics, visit their official website or follow them on social media for real-time news and announcements.
Overview of the Phase 2b CORAL Trial
The Phase 2b trial, known as the Cough Reduction in IPF with nalbuphine ER (CORAL), tested the effectiveness of nalbuphine ER across three different dosages: 27 mg, 54 mg, and 108 mg, administered twice daily over a period of six weeks. A total of 165 patients with chronic cough related to IPF participated in this double-blind, placebo-controlled study.
The primary metric for efficacy in this trial was the reduction in 24-hour cough frequency, meticulously recorded through objective monitoring systems. Remarkably, patients who received nalbuphine ER showed a statistically significant decline in their coughs, with over 60% attaining at least a 50% reduction by the end of the six-week period compared to baseline measurements. This result is a crucial milestone in demonstrating the potential impact of nalbuphine ER on patients' quality of life, as chronic coughing in IPF patients can reach overwhelming frequencies of up to 1,500 times a day.
Insights from Key Figures
James Cassella, PhD, the Chief Development Officer at Trevi Therapeutics, expressed enthusiasm about the findings, stating that the results validate the importance of addressing chronic coughs in IPF patients. He emphasized that a significant number of participants achieved remarkable improvements, indicating that nalbuphine ER could play a vital role in managing symptoms.
Moreover, Dr. Philip Molyneaux, a Professor of Pulmonary Medicine at the Royal Brompton Hospital, highlighted the persistent challenges chronic cough presents for his patients with IPF. The consistency observed between patient-reported outcomes and objective data was particularly gratifying, underscoring that patients felt genuine relief alongside measured improvements in cough frequency.
Safety Profile and Adverse Events
The safety assessments conducted during the CORAL trial largely aligned with the previously established profile of nalbuphine ER. Discontinuation rates due to adverse events were comparable between the treatment and placebo groups, standing at 5.6% and 5.0%, respectively. The trial reported a spectrum of adverse events, with nausea, dizziness, and fatigue among the most common. Even serious adverse events were notably fewer in the nalbuphine ER group as opposed to the placebo group, an encouraging sign that the treatment was well-tolerated.
The Necessity of Effective Treatment Options
The significance of addressing chronic cough in patients with IPF cannot be overstated. Currently, with around 150,000 individuals in the U.S. diagnosed with IPF, the need for FDA-approved treatments targeting chronic cough remains unmet. The burden of symptoms can severely affect patients' daily lives, resulting in heightened morbidity and negatively impacting their overall well-being.
The Future for Trevi Therapeutics
With promising data from the CORAL trial, Trevi Therapeutics is set to advance its efforts in developing nalbuphine ER, now branded as Haduvio™, which has shown efficacy in addressing chronic cough symptoms both in IPF and non-IPF related conditions. Trevi is committed to further studies to validate these findings and potentially seek regulatory approvals, heralding a hopeful future for countless individuals suffering from chronic cough.
For ongoing updates and more information about Trevi Therapeutics, visit their official website or follow them on social media for real-time news and announcements.
Topics Health）
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