Trevi Therapeutics has announced that its Phase IIb CORAL trial of Haduvio in treating idiopathic pulmonary fibrosis (IPF) subjects with chronic cough, will continue with its current sample size of 160 participants.
This decision follows a positive planned sample size re-estimation (SSRE) analysis. It was carried out on the highest dose group, receiving 108mg of Haduvio two times a day, after half of the targeted enrolment completed the six-week treatment.
The analysis concluded that the trial should proceed as initially planned, ensuring a conditional power of 80% or higher. The SSRE also considered other potential outcomes such as increasing the sample size or declaring the trial futile, but neither of these actions was recommended.
The double-blind, placebo-controlled, parallel-arm, randomised study aims to assess three doses of the therapy against a placebo in individuals with the given condition.
Around 160 IPF subjects with chronic cough are being randomised to receive one of the three doses of Haduvio or a placebo for a period of six weeks.
This includes a two-week titration phase to reach the target dose, with four weeks of treatment at a fixed dose to follow.
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By GlobalDataThe trial’s primary efficacy endpoint is to measure the relative change in cough frequency for 24 hours at the end of week six compared to the baseline, with the therapy’s performance being measured against that of the placebo with objective cough monitor VitaloJAK being used for assessment
The study has enrolled 75% of its targeted participants, and the company anticipates releasing the topline outcomes of the complete trial in the first half of next year.
Trevi Therapeutics CEO and president Jennifer Good said: “We are pleased that the SSRE outcome supports the continued execution of the CORAL trial with the total number of patients as originally planned.
“This positive SSRE outcome is reassuring and confirms the key powering assumptions of the trial design. We believe this is additional confirmation of the strong efficacy observed in the Phase IIa CANAL trial in IPF cough and 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.”
In November last year, the company began a Phase IIa RIVER clinical trial of Haduvio to treat refractory chronic cough.
