Trevi Therapeutics announced positive interim analysis results of the Phase 2 Cough And NALbuphine (CANAL) trial of its investigational therapy Haduvio™ (nalbuphine ER) in idiopathic pulmonary fibrosis patients (IPF) suffering from chronic cough, establishing proof of concept. Further patient recruitment in the trial will stop based on the strength and consistency of the data.
The company conducted a statistical analysis to assess the probability of success of CANAL based on the interim data. The results of that analysis revealed that there was a 100% chance of success on existing data and the Company has moved to end screening and conclude enrollment into CANAL. The interim analysis (N=26) was statistically significant on the primary efficacy endpoint, demonstrating a 52% placebo-adjusted reduction in the geometric mean percent change in daytime cough events (p<0.0001, conditional power 100%) for Haduvio. The interim analysis was conducted by an independent statistical team according to the pre-specified endpoint in the protocol.
"We are excited about the clinically and highly statistically significant results of Haduvio in the CANAL trial and the potential to treat chronic cough in IPF patients," said Bill Forbes, Chief Development Officer at Trevi Therapeutics. "Chronic cough in patients with IPF is a serious complication of a terminal disease with no approved therapies. 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."