Haduvio Greatly Reduces Coughing in IPF Patients in Phase 2 Trial

Nearly all patients on Haduvio experienced a reduction in cough frequency

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Treatment with Haduvio (nalbuphine extended-release tablets) significantly reduced coughing for people with idiopathic pulmonary fibrosis (IPF), according to top-line data from the Phase 2 CANAL trial.

“It is very promising to see such a significant reduction in chronic cough in IPF patients with [Haduvio],” Peter Dicpinigaitis, MD, a professor at the Albert Einstein College of Medicine and director of the Montefiore Cough Center, in New York, said in a press release. “There is a large unmet need for chronic cough therapies and I believe there is broad potential to improve patients’ lives with an oral therapy with a central mechanism of action.”

Cough is one of the most common symptoms of IPF, and no therapies have been approved specifically to ease coughing due to IPF.

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What is Haduvio?

Haduvio, an investigational therapy developed by Trevi Therapeutics, is a formulation of nalbuphine, which has been approved for decades in injectable form as a pain medication. The therapy modulates the activity of specific cell receptors known to be involved in cough and itching.

In the Phase 2 CANAL trial (NCT04030026), adults with IPF (ages 18–80) were given either increasing doses of Haduvio, or a placebo, for three weeks. Then, after a two-week washout period, participants originally given Haduvio switched over to the placebo, and vice versa, for an additional three weeks.

The study’s main goal was to assess the effect of treatment on coughing frequency, as measured by a digital cough monitor.

An interim analysis conducted earlier this year suggested the therapy was able to reduce coughing frequency in IPF patients. The trial completed enrollment in March, and the top-line analysis now announced includes data for 38 participants.

Results showed that Haduvio reduced daytime cough frequency by 75.1%, compared to 22.6% with the placebo — a statistically significant difference of 52.5%.

“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,” said Jennifer Good, president and CEO of Trevi Therapeutics.

Nearly all patients (97%) on Haduvio experienced a reduction of at least 30% in 24-hour cough frequency, compared to 35% of those on placebo, according to a post-hoc analysis, which is designed and carried out after trial data are already available.

“We analyzed the change of 24hr cough frequency as well as daytime cough frequency and observed consistent reductions for both measurements,” Good said.

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Patient-reported assessments of coughing severity, namely the EXACT2: Cough Frequency Score and the Cough Severity Numerical Rating Scale, also showed statistically significant differences favoring Haduvio over placebo. Clinician-rated assessments also showed significantly higher rates of improvement for patients on Haduvio compared with placebo (62% vs. 19%).

Safety findings in CANAL were generally consistent with those seen in previous studies of Haduvio and no serious side effects related to the investigational treatment were reported. The most common adverse events reported in the study included nausea, fatigue, constipation, dizziness, sleepiness, vomiting, headache, anxiety, and depression.

“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,” Good said. “We would like to thank the CANAL trial participants and investigators for their contribution to this research as we look to improve IPF patients’ quality of life.”