Trevi Therapeutics has reported positive data from the Phase II CANAL clinical trial of its investigational therapy, Haduvio (oral nalbuphine extended-release (ER)), to treat chronic cough in idiopathic pulmonary fibrosis (IPF).

Carried out in the UK, the two-treatment, randomised, double-blind, placebo-controlled, two-period crossover trial assessed the safety and efficacy of nalbuphine ER.

Assessing the impact of nalbuphine ER tablets on the mean daytime cough frequency at day 22 versus placebo as evaluated by an objective cough monitor was the trial’s primary efficacy endpoint.

According to findings, treatment with Haduvio offered a statistically significant 52.5% change versus placebo on the primary endpoint.

Additionally, the therapy led to a 75.1% decline in the geometric mean percent change in daytime cough frequency.

The crucial secondary endpoints on the subject- and clinician-reported outcomes were also found to be statistically significant.

The safety data of Haduvio from the trial was in line with already reported ones from prior studies. 

Trevi Therapeutics president and CEO Jennifer Good said: “We are pleased to announce the positive results from the full set of subjects from the CANAL trial, which are consistent with the previously announced interim analysis and further demonstrated that Haduvio has the potential to reduce IPF patients’ cough.

“We analysed the change of 24hr cough frequency as well as daytime cough frequency and observed consistent reductions for both measurements.

“There are no approved therapies for chronic cough in these patients, and we are excited to continue our development in this indication and look forward to starting our next clinical trial for these patients in the first half of 2023.”

In March this year, the company completed subject enrolment in the CANAL trial