Trevi Therapeutics (NASDAQ:TRVI) announced positive topline results from its Phase 2a RIVER study of oral nalbuphine ER (Haduvio) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).
According to the company, Haduvio met the primary endpoint with a statistically significant reduction in the objective 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis.
“I am happy to share these robust positive results from our Phase 2a RIVER trial in refractory chronic cough which has been a difficult-to-treat indication with no approved therapies in the U.S.,” said Jennifer Good, president and CEO of Trevi.
“The RIVER trial demonstrated that Haduvio was highly effective, and worked quickly at the lowest dose tested across a broad range of cough counts. These results, coupled with our existing IPF chronic cough results, are further evidence of the effectiveness of Haduvio’s central and peripheral KAMA mechanism in treating these difficult neurological cough conditions which are so disruptive to patients’ lives,” she said.
James Cassella, Ph.D., chief development officer of Trevi added, “The results from the RIVER trial were highly statistically significant with consistent outcomes across the primary and analyzed secondary endpoints as well as for patients with moderate or severe baseline cough frequency. We look forward to advancing development of nalbuphine ER in the hopes of providing relief for the significant unmet need for these chronic cough patients. Based on these results, we plan to discuss next steps with the FDA and anticipate initiating the next study after we receive their input. Thank you to all the patients and investigators who contributed to our trials and continue to advance clinical research to find a treatment for chronic cough.”
Professor Jacky Smith, professor of respiratory medicine at the University of Manchester, commented, “I am excited to see the positive results from the Phase 2a RIVER trial and the potential role nalbuphine ER could have in therapy for RCC patients. RCC significantly impacts patients’ lives both physically and psychologically, resulting in chest pain, urinary incontinence, depression, exhaustion, dizziness and much more. Therapies are desperately needed as patients continue to suffer from this debilitating disease.”
