TRVI - Trevi adds 19% on full data set from mid-stage cough study

• Clinical-stage biopharma, Trevi Therapeutics, Inc. ( NASDAQ: TRVI ) gained 19% pre-market Monday after the company announced complete data from its Phase 2 trial for lead asset Haduvio for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF)
• U.K.-based CANAL study was designed to compare Haduvio, an oral extended-release formulation of pain therapy nalbuphine, against placebo in terms of the mean daytime cough frequency at Day 22 as the primary endpoint, as measured by an objective cough monitor.
• The full set of subjects (N=38) reached the primary endpoint with statistical significance indicating a 52.5% change in daytime cough frequency for Haduvio compared to placebo (p<0.0001). The reduction of cough frequency stood at ~76.1% and 25.3% in Haduvio and placebo arms, respectively.
• The safety profile was in line with data from previous studies for the treatment, and two adverse events were found to be unrelated to the experimental therapy. TRVI expects to start the next trial for this indication in H1 2023.
• A previous readout from 26 patients in the CANAL trial indicated a 52% placebo-adjusted reduction in daytime cough events for Haduvio.

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