secwatch.observer — SEC 8-K summary
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Issuer:     Trevi Therapeutics, Inc. (TRVI)
CIK:        0001563880
Form:       8-K
Filed at:   2025-06-02T23:59:59+00:00
Accession:  0001193125-25-132890
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Trevi Therapeutics reports positive Phase 2b topline results for Haduvio in IPF chronic cough
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- Primary endpoint met: 60.2% reduction in 24-hour cough frequency at 108 mg BID (p<0.0001) vs 16.9% placebo.
- Statistically significant improvements on cough-severity NRS and E-RS:IPF Cough Subscale at 108 mg and 54 mg BID.
- Discontinuation due to AEs similar between Haduvio (5.6%) and placebo (5.0%); safety profile consistent with prior trials.
- Expects end-of-Phase 2 FDA meeting in H2 2025; plans Phase 2b trial in refractory chronic cough starting H1 2026.
- Also plans to initiate clinical trial of Haduvio for non-IPF interstitial lung disease cough in H2 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563880/000119312525132890/0001193125-25-132890-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563880/000119312525132890/d949267d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-132890

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