Trevi Therapeutics Accelerates Execution in Key Programs
Trevi Therapeutics has entered a pivotal phase of its execution plan, with multiple programs advancing towards key milestones. In a recent conference call, Jennifer Good, President and CEO, provided an update on the company's progress and future plans.
One of the key areas of focus is Trevi's IPF-related chronic cough program. Following a positive FDA meeting in Q1 2026, the team has finalized study protocols for its phase III trials. The first of these studies is expected to initiate this quarter, with the second following in the second half of the year.
Trevi also intends to submit a meeting request and protocol to the FDA for its non-IPF interstitial lung disease (ILD)-related chronic cough program. This program will utilize an adaptive phase II/III study design to confirm dose and powering assumptions prior to rolling into one pivotal phase III study for approval.
According to Jennifer Good, the non-IPF ILD population mirrors that of patients in Trevi's IPF trial, including those with established lung fibrosis and chronic cough. This similarity provides synergies with Trevi's existing studies, as these patients are often seen by the same pulmonologists.
Additionally, Trevi expects to initiate a phase II-B parallel arm dose-ranging trial for refractory chronic cough in Q2 2026. This study will feature three doses and placebo, with a sample size re-estimation (SSRE) at 50% completion. The SSRE readout is expected in Q4 2026.
Trevi's intellectual property portfolio has also seen advancement. The company owns worldwide rights to its drug and is actively prosecuting incremental patent coverage. This quarter, a core method of treatment patent was issued for IPF-related chronic cough in Europe, providing protection through 2039. Additional applications have been filed in the US, which if issued would extend patent coverage through 2046.
Dr. James Cassella, Chief Development Officer, Farrell Simon, Chief Commercial Officer, and David Hastings, Chief Financial Officer, also participated in the call, with Dave and Jennifer keeping their comments brief as they will present a more detailed update at the company's Investor and Analyst Day this Thursday.
