"Trevi Therapeutics to Host Conference Call and Webcast on March 10th to Share Topline Results from the Phase 2a RIVER Trial of Haduvio in Patients with Refractory Chronic Cough"

On March 10th, Trevi Therapeutics is set to host a conference call and webcast to share the topline results from the Phase 2a RIVER trial of Haduvio in patients with refractory chronic cough (RCC). This event marks a pivotal moment for the biotech company, as the outcomes of this trial could significantly impact its strategic direction and market valuation. The RIVER trial, a randomized, double-blind, placebo-controlled study conducted in the UK and Canada, aims to assess the efficacy, safety, and tolerability of Haduvio in RCC patients. With approximately 60 adult patients enrolled, the primary endpoint is the mean change in 24-hour cough frequency, measured by an objective cough monitor. Secondary endpoints include patient-reported outcome measures for cough frequency and severity.

The stakes are high for Trevi Therapeutics. The lack of approved therapies in the U.S. for RCC presents a clear market opportunity if the upcoming data is positive. The company's financial position, with $107.6 million in estimated cash reserves providing runway into the second half of 2026, supports this strategic direction by ensuring sufficient resources for completing both clinical trials and potentially initiating commercial activities. The convergence of two major clinical readouts in the first half of 2025 creates a binary catalyst window that could significantly impact valuation. Success in either indication could drive substantial value creation given the current unmet medical needs and lack of approved treatments.



The success of the Phase 2a RIVER trial significantly influences the strategic direction and future clinical development plans for Trevi Therapeutics, particularly in relation to their Phase 2b CORAL trial. The completion of patient enrollment in the Phase 2a RIVER trial for refractory chronic cough (RCC) in October 2024, with topline results expected in the first quarter of 2025, marks a critical milestone. This success provides valuable data and insights that can be leveraged to optimize the ongoing Phase 2b CORAL trial for idiopathic pulmonary fibrosis (IPF) patients with chronic cough. The positive outcomes from the sample size re-estimation (SSRE) analysis for the CORAL trial, which required no change to the current sample size of 160 patients, further validate the trial's design and statistical power. This ensures that the CORAL trial can proceed as planned, maintaining its pre-specified conditional power of 80% or greater. The convergence of both trial results in the first half of 2025 creates a significant catalyst window that could validate Haduvio's potential in two substantial market opportunities—IPF chronic cough and RCC. The successful Human Abuse Potential study strengthens Haduvio's safety profile and regulatory pathway, positioning Trevi Therapeutics for potential commercial preparation activities if the results are positive. The company's financial position, with $107.6 million in estimated cash reserves providing runway into the second half of 2026, supports this strategic direction by ensuring sufficient resources for completing both clinical trials and potentially initiating commercial activities.

The potential regulatory and commercialization pathways for Haduvio if the Phase 2a RIVER trial results are favorable are promising. The successful Human Abuse Potential study strengthens Haduvio's safety profile and regulatory pathway. The lack of approved therapies in the U.S. for refractory chronic cough (RCC) presents a clear market opportunity if the upcoming data is positive. The preliminary cash position of $107.6 million provides approximately 18 months of operational runway, a healthy cushion for completing both clinical trials and potentially initiating commercial preparation activities if results are positive. This financial position is particularly strategic given the biotech sector's challenging funding environment. The company's market cap of $372.7 million suggests the market is cautiously optimistic but hasn't fully priced in success across both indications. The convergence of two major clinical readouts in H1 2025 creates a binary catalyst window that could significantly impact valuation. Success in either indication could drive substantial value creation given the current unmet medical needs and lack of approved treatments. The efficient trial execution and maintenance of original sample size in CORAL suggests disciplined operational and capital management.

In conclusion, the upcoming conference call and webcast on March 10th by Trevi Therapeutics to share the topline results from the Phase 2a RIVER trial of Haduvio in patients with refractory chronic cough is a moment of truth for the company. The outcomes of this trial could validate Haduvio's potential in treating RCC, a condition with significant unmet medical needs. The strategic direction and future clinical development plans for Trevi Therapeutics, particularly in relation to their Phase 2b CORAL trial, are heavily influenced by the success of the RIVER trial. The potential regulatory and commercialization pathways for Haduvio are promising, and the company's financial position supports its strategic direction. The convergence of two major clinical readouts in the first half of 2025 creates a binary catalyst window that could significantly impact valuation. Success in either indication could drive substantial value creation given the current unmet medical needs and lack of approved treatments. The efficient trial execution and maintenance of original sample size in CORAL suggests disciplined operational and capital management.