8-K: Trevi Therapeutics Announces Positive Topline Results from Phase 2a RIVER Trial of Haduvio for Refractory Chronic Cough

Trevi Therapeutics' Haduvio demonstrates statistically significant reduction in cough frequency in Phase 2a RIVER trial for refractory chronic cough.

Summary

• Trevi Therapeutics announced positive topline results from its Phase 2a RIVER trial of Haduvio for the treatment of patients with refractory chronic cough (RCC).
• The trial met its primary endpoint, showing a statistically significant reduction of 67% in the objective 24-hour cough frequency from baseline and 57% on a placebo-adjusted basis (p<0.0001).
• The Phase 2a RIVER trial was a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study.
• Each treatment period lasted 21 days, separated by a 21-day washout period.
• Patients were titrated with Haduvio at 27 mg twice daily (BID), 54 mg BID and 108 mg BID.
• The primary endpoint was the mean change in 24-hour cough frequency at Day 21.
• The full analysis set (FAS) population included patients who received at least one dose of study drug and had objective cough count data on both Baseline and Day 21 (N=59).
• Haduvio demonstrated a statistically-significant reduction in 24-hour cough frequency of 66% in the severe cough (20+ coughs/hour) subgroup (p<0.0001) and 68% in the moderate cough (10-19 coughs/hour) subgroup (p<0.0001).
• 84% of Haduvio patients had at least a 30% reduction in 24-hour cough frequency vs. baseline, compared to 29% of placebo patients (p<0.0001).
• A statistically-significant reduction in 24-hour cough frequency was seen as early as Day 7 (27 mg BID) for patients on Haduvio (p<0.0001).
• Patients on Haduvio experienced a statistically-significant improvement in patient reported outcomes compared to placebo as early as Day 7 (27 mg BID) in the Cough Severity Visual Analog Scale and the Patient-Reported Cough Frequency.
• The safety results were generally consistent with the known safety profile of Haduvio.
• The most common adverse events included constipation, nausea, somnolence, headache, dizziness, and fatigue, and there were no treatment emergent serious adverse events.
• The Company plans to discuss next steps with the FDA and anticipates initiating the next study after receiving FDA input.

Sentiment

Score: 8

Explanation: The document presents positive clinical trial results, suggesting a promising outlook for Haduvio and Trevi Therapeutics. The statistically significant improvements and consistent safety profile contribute to a positive sentiment.

Positives

• Haduvio demonstrated a statistically significant reduction in cough frequency in the Phase 2a RIVER trial.
• The drug showed efficacy in both severe and moderate cough subgroups.
• A significant percentage of patients experienced a clinically meaningful reduction in cough frequency.
• The drug's effect was observed early in the treatment period.
• Patient-reported outcomes improved significantly with Haduvio treatment.
• The safety profile was consistent with previous trials, suggesting no new safety concerns.

Negatives

• The most common adverse events experienced included constipation, nausea, somnolence, headache, dizziness, and fatigue.

Risks

• The success of future clinical trials is uncertain.
• Regulatory authorities' views on the data and next steps are uncertain.
• The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially.

Future Outlook

The Company plans to discuss next steps with the FDA and anticipates initiating the next study after receiving FDA input. The company is making forward-looking statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans with respect to clinical trials and clinical data.

Industry Context

The announcement positions Trevi Therapeutics as a potential player in the treatment of refractory chronic cough, an area with unmet medical needs. The results could impact the competitive landscape for cough treatments.

Stakeholder Impact

• Shareholders may react positively to the positive clinical trial results.
• Patients with refractory chronic cough may benefit from a new treatment option.
• The FDA will need to review the data and provide input on the next steps.

Next Steps

• The Company plans to discuss next steps with the FDA.
• The Company anticipates initiating the next study after receiving FDA input.

Key Dates