Trevi starts Phase 3 OCEAN-1 and Phase 2b LAKE trials for Haduvio
Trevi Therapeutics reported second-quarter 2026 results, with cash and securities of $318.9 million and a cash runway extended into 2030.
Trevi Therapeutics said it initiated the Phase 3 OCEAN-1 trial in the second quarter of 2026, the first of two parallel Phase 3 studies in patients with IPF-related chronic cough.1 Topline data from the 52-week fixed-dosing OCEAN-1 trial is expected in the first half of 2028.1 The company also said it plans to start the 12-week fixed-dosing OCEAN-2 trial in the third quarter of 2026, with topline results expected in the second half of 2027.1
On the refractory chronic cough (RCC) program, Trevi initiated the Phase 2b LAKE trial in patients with RCC during the second quarter of 2026.1 The protocol calls for a sample size re-estimation analysis once half of participants complete treatment, expected in the fourth quarter of 2026,1 and the company plans to report that outcome when available, with topline results from the trial expected in the second half of 2027.1
For non-IPF interstitial lung disease-related chronic cough, Trevi said it submitted a meeting request to the FDA to discuss the proposed development plan and align on regulatory strategy and requirements to support registration.1
On finances, the company ended the second quarter of 2026 with $318.9 million in cash, cash equivalents and marketable securities,1 after it completed an underwritten common stock offering in April 2026 that generated net proceeds of about $162.3 million.1 Trevi said this cash position is expected to extend its cash runway into 2030 and to fund Haduvio's development for IPF-related chronic cough through potential FDA approval.1 The company reported a net loss of $17.8 million for the second quarter of 2026, compared with a net loss of $12.3 million in the same period of 2025.1
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