Trevi Therapeutics has linked its oral, extended-release formulation of the opioid analgesic nalbuphine to reduced cough frequency in idiopathic pulmonary fibrosis (IPF) patients, prompting it to wrap the phase 2 trial up early and push deeper into the clinic.
As of the interim analysis, Trevi had primary endpoint data on 26 participants. In that population, Trevi saw a 52% placebo-adjusted reduction in the geometric mean percent change in daytime cough events. Trevi concluded that the trial was already guaranteed to meet its primary endpoint and, as such, moved to stop the study early. The trial was supposed to enroll around 60 participants.
“Based on these significant results and consistency of the data, we are ending recruitment into the CANAL trial to focus on accelerating Haduvio into the next phase of development for chronic cough in patients with IPF,” Bill Forbes, chief development officer at Trevi, said in a statement.
After giving patients the extended-release Haduvio or placebo twice a day, Trevi measured the daytime cough frequency and compared it to baseline. The frequency fell 77.3% in the treatment arm, compared to a 25.7% decline in the control group.
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Trevi saw one serious adverse event in the trial but it wasn’t deemed to be treatment-related. With more than 1,000 people receiving the extended-release formulation of nalbuphine across multiple studies and the safety profile in the IPF trial matching existing evidence, Trevi thinks it has the data to move forward.
The next step is for Trevi to hold talks with regulatory agencies about the next study. Trevi is also getting ready to release full data from the IPF trial, including from around 15 additional patients enrolled after the interim analysis cutoff, in the third quarter.