Enrollment hits 75% for Phase 2b clinical trial of Haduvio for IPF
Study testing therapy for chronic cough still recruiting in 10 countries
Trevi Therapeutics announced that its ongoing Phase 2b clinical trial testing Haduvio (nalbuphine extended-release tablets) in people with idiopathic pulmonary fibrosis (IPF) who have chronic cough has reached 75% of its targeted patient enrollment.
The Phase 2b CORAL trial (NCT05964335) is still seeking to recruit a total of 160 patients — as confirmed by an independent sample size re-estimation analysis performed on the highest dose group after half of the participants were enrolled and completed six weeks of treatment. The analysis recommended that the trial should continue as planned to have a likelihood of generating statistically significant data of 80% or more.
To that end, the trial is continuing to recruit patients at sites in each of the 10 countries in which CORAL is now running. Among them are Australia, Canada, Chile, Turkey, and several European countries. Top-line data are expected in the first half of 2025, according to a company press release.
“We are pleased that the [sample size re-estimation] outcome supports the continued execution of the CORAL trial with the total number of patients as originally planned,” said Jennifer Good, Trevi’s president and CEO. “This positive [sample size re-estimation] outcome is reassuring and confirms the key powering assumptions of the trial design.”
According to Good, this is “an important milestone reaffirming our belief in Haduvio’s best-in-class and first-in-class potential for patients with IPF chronic cough where there are no approved therapies.”
Phase 2b trial follows Phase 1b clinical study that showed positive results
IPF is a chronic lung disease of unknown origin characterized by inflammation and tissue scarring, known as fibrosis, in the lungs. The accumulation of scar tissue causes the lungs to stiffen, making breathing more difficult and leading to symptoms of chronic cough, shortness of breath, and fatigue.
Haduvio is an oral extended-release formulation of nalbuphine, a compound that changes the activity of two protein receptors involved in the nerve-signaling pathways that mediate coughing. It targets nerves in the brain and spinal cord, which comprise the central nervous system, as well as those responsible for transmitting information between the brain and the rest of the body, called the peripheral nerves.
In a Phase 2a trial (NCT04030026) dubbed CANAL, the treatment was shown to significantly reduce coughing in people with IPF. Trial data showed that Haduvio significantly outperformed a placebo in its ability to reduce daytime cough frequency (reduction of 75.1% vs. 22.6%). Similar results were observed for 24-hour cough frequency (reduction of 76.1% vs. 25.3%).
We believe [the new trial analysis] is additional confirmation of the strong efficacy observed in the Phase 2a CANAL trial in IPF cough.
Based on these results, the company launched CORAL, which is now testing Haduvio in people with IPF and chronic cough. Participants are randomly assigned to receive one of three doses of the therapy — 27, 54, or 108 mg) — or a placebo, twice daily for six weeks.
Treatment doses will be gradually increased in the first two weeks until the target dose is reached. After that, participants will receive the target dose for four more weeks. The study’s main goal is to assess changes in 24-hour cough frequency, with secondary goals including patient-reported outcomes of cough, breathlessness, and life quality.
“We believe [the new analysis] is additional confirmation of the strong efficacy observed in the Phase 2a CANAL trial in IPF cough,” Good said.
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