US-based biopharmaceutical company Trevi Therapeutics has finished enrolling subjects in a Phase IIb trial of investigational Haduvio for treating chronic cough in idiopathic pulmonary fibrosis (IPF) patients.
The company expects to publish topline outcomes from the double-blind CORAL trial in the first half of this year.
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The placebo-controlled, parallel-arm trial will assess doses of 27mg, 54mg and 108mg, each administered twice a day over a period of six weeks.
Nearly 160 IPF patients with chronic cough have been randomised to receive either one of the three doses or a placebo.
The trial began with a two-week titration period to reach the target dose, followed by four weeks of fixed dosing.
Its primary efficacy endpoint is the relative change in 24-hour cough frequency at the end of week six compared to baseline for the therapy against placebo, measured using an objective cough monitor.
Secondary endpoints of the trial include subject-reported outcome measures for cough.
Trevi Therapeutics chief development officer James Cassella said: “The completion of enrolment in the Phase IIb CORAL trial is a significant milestone in the development of Haduvio for patients with idiopathic pulmonary fibrosis suffering from chronic cough.
“The results from this study will help us determine the optimal doses of Haduvio to move into our pivotal Phase III programme.”
Haduvio works on the cough reflex arc both centrally and peripherally as a kappa agonist, as well as a mu antagonist targeting opioid receptors involved in cough hypersensitivity.
The drug’s active ingredient is nalbuphine, which is not currently scheduled by the US Drug Enforcement Agency.
Trevi is also developing Haduvio for refractory chronic cough, since there are currently no approved therapies for that indication in the US.
In February 2022, the company finished enrolling subjects in a Phase IIb/III trial of Haduvio for treating pruritus associated with prurigo nodularis.
