secwatch.observer — SEC 8-K summary
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Issuer:     Trevi Therapeutics, Inc. (TRVI)
CIK:        0001563880
Form:       8-K
Filed at:   2025-03-10T23:59:59+00:00
Accession:  0000950170-25-036503
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

Trevi's Haduvio meets Phase 2a RIVER primary endpoint; 57% placebo-adjusted cough reduction
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- Primary endpoint: 67% reduction from baseline in 24-hour cough frequency; 57% placebo-adjusted (p<0.0001).
- 84% of Haduvio patients had ≥30% reduction vs 29% placebo; early response at Day 7 (27 mg BID).
- Severe cough subgroup (20+ coughs/hr): 66% reduction; moderate (10-19/hr): 68% reduction (p<0.0001).
- Safety profile consistent with prior Haduvio trials; no treatment-emergent serious adverse events.
- Trevi plans to discuss results with FDA and initiate next study after FDA input.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1563880/000095017025036503/0000950170-25-036503-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1563880/000095017025036503/trvi-20250310.htm
  HTML page:      https://secwatch.observer/filing/0000950170-25-036503

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer