Trevi Therapeutics (NASDAQ:TRVI) said it remains on track to report results from its lead chronic cough trials in 2027 and 2028, while preparing a new study in patients with interstitial lung disease other than idiopathic pulmonary fibrosis.
On its third-quarter 2026 earnings call, the company also outlined an upcoming assessment that could increase enrollment in its refractory chronic cough trial. Chief Financial Officer David Hastings said Trevi ended the quarter with approximately $299 million in cash, cash equivalents and marketable securities, providing a runway into 2030.
Lead trials progress, with results expected in 2027 and 2028
President and CEO Jennifer Good said Trevi has initiated both OCEAN-1 and OCEAN-2, its trials of Haduvio for chronic cough associated with idiopathic pulmonary fibrosis, or IPF. The company has received regulatory authorization in every country where the trials are being conducted and is working to activate sites and screen patients.
Trevi expects results from the 12-week OCEAN-2 study in the second half of 2027. Results from OCEAN-1, which has a 24-week efficacy endpoint and 52 weeks of safety monitoring, are expected in the first half of 2028. Good said the company would provide an update when 50% of patients have been randomized in each trial.
Chief Development Officer James Cassella said Trevi plans to report the two studies separately but submit a comprehensive new drug application incorporating both trials and integrated safety and efficacy analyses.
New study planned for non-IPF lung disease
Following an October meeting with the Food and Drug Administration, Trevi plans to begin a Phase 2 dose-ranging study in approximately 120 patients with chronic cough associated with interstitial lung disease, or ILD, excluding those with IPF. The trial is expected to start in the first quarter of 2027 and produce top-line data in the first half of 2028.
Good said the study will evaluate two doses of Haduvio over 12 weeks of fixed dosing. The protocol has been written and will be submitted to the FDA for comment. Trevi expects the study to use sites that overlap with its North American IPF program.
Cassella said the trial is intended to determine appropriate doses for a potential Phase 3 program. He said Trevi hopes that one Phase 3 study, supported by data from the IPF program, could form the basis of a supplemental application for the non-IPF ILD population.
During the question-and-answer session, Cassella said the company was considering a minimum of approximately 10% lung fibrosis for enrollment. He said Trevi did not expect a 27-milligram once-daily dose to be sufficient in ILD, based on its experience with a twice-daily dose in IPF.
Refractory cough trial faces enrollment assessment
Trevi expects an independent assessment of its Phase 2b LAKE trial in refractory chronic cough in early first-quarter 2027. The analysis will take place after 50 patients complete the study and will determine whether its planned enrollment of 100 patients should increase to as many as 152.
Good said the independent statistical team will assess conditional power—the likelihood of achieving a statistically significant result under the analysis assumptions—without sharing the underlying unblinded data with Trevi. If conditional power is at least 80%, the company plans to maintain the original enrollment target. If it is between 40% and 80%, enrollment could increase proportionally.
If conditional power is below 40%, suggesting futility, Good said Trevi would still plan to complete enrollment of 100 patients and examine the final data. Cassella said the assessment will be based on the trial’s highest dose, 54 milligrams twice daily.
Trevi continues to expect full LAKE results in the second half of 2027. Cassella said a full increase to 152 patients would still allow a readout by the end of that year.
Cash runway and commercial plans
Hastings said Trevi’s projected cash runway includes funding for the IPF program through potential FDA approval, the non-IPF ILD study through top-line results and the ongoing LAKE trial. It also includes pre-commercial activities, but excludes a Haduvio commercial launch and any Phase 3 trials in refractory chronic cough or non-IPF ILD.
Chief Commercial Officer Farrell Simon said the company is currently focused on developing the IPF and ILD markets. Trevi has reached approximately 93% of pulmonologists through an unbranded campaign discussing the burden of chronic cough, he said.
Good said Trevi intends to retain global commercial rights to its program, though it could consider options such as co-promotion. She also said a newly issued patent covering dosing in patients with hepatic impairment and non-IPF ILD would extend that protection to 2041.
About Trevi Therapeutics (NASDAQ:TRVI)
Trevi Therapeutics, Inc is a clinical-stage biopharmaceutical company developing treatments for chronic cough and chronic itch. Its lead candidate, Haduvio (oral extended-release nalbuphine), is being studied for conditions including idiopathic pulmonary fibrosis, other interstitial lung diseases and chronic pruritus associated with prurigo nodularis.
Nalbuphine acts on opioid receptors, and Trevi is evaluating its potential to reduce these symptoms. The company’s development programs are focused on clinical research; Haduvio is not an approved treatment.
Trevi is headquartered in New Haven, Connecticut, and its operations are centered on developing its drug candidate.
