Trevi Therapeutics Inc (NASDAQ:TRVI) has announced positive interim analysis results from Phase 2 CANAL trial of Haduvio (nalbuphine ER) in idiopathic pulmonary fibrosis patients (IPF) suffering from chronic cough.
- The company conducted a statistical analysis to assess the probability of success of CANAL based on the interim data.
- 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 for Haduvio.
- An independent statistical team conducted the interim analysis according to the pre-specified endpoint in the protocol.
- Nalbuphine ER has been well-tolerated in the CANAL trial. The safety profile remains consistent with prior studies with no new safety signals.
- One SAE has been reported in the CANAL trial to date and was not considered treatment-related.
- Trevi has determined to stop further recruitment into the CANAL trial and plans to initiate discussions with Health Authorities regarding the next study.
- The company plans to report data from the full CANAL trial early in Q3 of 2022. It will include the patients enrolled in January and February of this year, with approximately 40 subjects.
- Price Action: TRVI shares are up 41.3% at $0.65 during the premarket session on the last check Thursday.
