Trevi Therapeutics Breaks Ground on Phase III Trials for Haduvio, Accelerating its Journey to Approval
Trevi Therapeutics has made significant strides in its development program for Haduvio, a treatment aimed at addressing idiopathic pulmonary fibrosis (IPF)-related chronic cough. According to the company's recent Q4 2025 earnings conference call transcript, Trevi secured a clear path forward for registration trials following a positive end-of-phase II meeting with the FDA. This milestone marks a crucial step towards initiating phase III studies and ultimately securing approval for Haduvio.
During the call, Jennifer Good, President and CEO of Trevi Therapeutics, highlighted the company's progress in 2025, driven by promising data readouts from both the CORAL trial and the RIVER trial. These positive results enabled the company to raise capital, positioning it for the next phase of trials.
Good emphasized that this momentum has carried into the new year as Trevi prepares to initiate its next set of clinical trials. The recently concluded end-of-phase II meeting with the FDA was described by Good as "very collaborative," with the agency providing valuable input and guidance on the development program for Haduvio.
Key takeaways from the meeting include agreement on the primary endpoint using the objective cough monitor, discussion of proposed key secondary endpoints, and evaluation of these endpoints. Trevi plans to conduct two pivotal phase III clinical trials in parallel, with the first trial scheduled to initiate in the second quarter of this year and the second expected to initiate in the second half.
The company's President and CEO emphasized that the team at Trevi has been moving aggressively to initiate its phase III program. This includes planning for a global 52-week trial with a primary efficacy endpoint following 24 weeks of fixed dosing, as well as a confirmatory phase III trial with a primary efficacy endpoint at 12 weeks.
Trevi's Chief Financial Officer, David Hastings, was welcomed to his first official earnings call and business update. His experience has already been felt in the company, and Trevi feels fortunate to have him on board at this important time of execution and growth.
