Trevi to launch Phase 2 trials to test Haduvio for IPF-related cough

Earlier data show coughing frequency reduced in most patients on oral Haduvio

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Trevi Therapeutics is planning to launch two new clinical trials this fall to test Haduvio (nalbuphine extended-release tablets) for chronic cough in people with idiopathic pulmonary fibrosis (IPF).

One of the trials will be a Phase 2b study to identify the best dose of the medication for people with IPF. The other is a Phase 1b trial to investigate how the lungs and other parts of the respiratory system are affected in IPF.

Trevi is also planning a Phase 2a study to test Haduvio in people with refractory (treatment-resistant) chronic cough. All three studies are expected to start before the end of the year.

“Our development plans remain on track in our chronic cough programs and we expect to initiate clinical trials in both chronic cough in IPF and refractory chronic cough in the second half of this year,” Jennifer Good, Trevi’s president and CEO, said in a company press release. “We are currently in the regulatory submission phase in various countries to support trial initiations.”

“We were encouraged by the high degree of scientific and clinical interest at the medical meetings held this quarter surrounding our data generated in chronic cough in IPF and the potential of Haduvio’s mechanism of action to broadly treat chronic cough,” Good said.

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Chronic cough is common symptom of IPF

Chronic cough is one of the most common symptoms of IPF. No medications are specifically approved to treat IPF-related coughing, and available cough suppressants often aren’t effective.

Haduvio is an oral formulation of nalbuphine, which is expected to help relieve coughing and itching by changing the activity of certain cellular receptors that help the body register sensations. An injectable form of nalbuphine has been used for decades to help relieve pain. Trevi won approval of a patent for Haduvio to treat IPF earlier this year.

The announcement of the new IPF trials came after the therapy showed promise in a Phase 2 trial called CANAL (NCT04030026). Top-line findings from the study were announced last year, and full results were recently published in the journal NEJM Evidence in a study, titled “Nalbuphine Tablets for Cough in Patients with Idiopathic Pulmonary Fibrosis.”

In the CANAL study, 41 people with IPF-related chronic cough were given Haduvio or a placebo for 22 days. Then, after a two-week washout period, patients originally given the therapy were given placebo, and vice versa, for another 22 days.

The study’s main goal was to evaluate the effect of Haduvio on cough frequency during the day, as measured by an electronic cough monitor.

As previously reported, results showed that Haduvio significantly reduced daytime cough frequency compared with placebo (by 75.1% vs. 22.6%).

Similar results were observed in 24-hour cough frequency, with Haduvio lowering this parameter by 76.1% and placebo by 25.3%.

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62% of patients experienced improvement in coughing with Haduvio

Based on clinician-rated measures, more than half (62%) of the patients experienced an improvement in coughing with Haduvio, compared with less than one in five (19%) with placebo.

“Our short-term crossover trial demonstrated a statistically significant reduction in IPF-related cough,” the researchers wrote.

The most common side effects associated with Haduvio in CANAL were digestive issues such as nausea, constipation, and/or vomiting, as well as neurological problems like fatigue, dizziness, and/or sleepiness. Nine patients stopped treatment early due to side effects, with most discontinuing within the first few days of starting on Haduvio.

Overall, researchers noted that findings from CANAL “are encouraging enough to merit further assessment in longer and larger clinical studies.”

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