Trevi Therapeutics Advances Novel Cough Therapy, Bolsters Financial Runway

NEW YORK, NY – November 13, 2025

Biotech Firm Secures Financial Future, Presents Promising Data

Trevi Therapeutics announced strong financial results for the third quarter of 2025, coupled with encouraging data from ongoing clinical trials of its lead candidate, Haduvio, an oral nalbuphine ER designed to treat chronic cough. The company’s robust cash position and positive trial outcomes position it for continued development and potential market leadership in a therapeutic area with significant unmet need. With a cash runway now extending into 2028, Trevi appears well-equipped to advance its pipeline and pursue regulatory approvals.

Novel Mechanism Targets Chronic Cough at the Source

Haduvio distinguishes itself through its unique dual mechanism of action, operating as both a kappa opioid agonist and a mu opioid antagonist (KAMA). Unlike traditional opioid cough suppressants, which can carry risks of addiction and respiratory depression, Haduvio aims to mitigate these side effects by simultaneously modulating opioid receptors. “The KAMA approach is really intriguing,” noted one pulmonology expert. “It’s a sophisticated way of targeting the cough reflex arc while minimizing the drawbacks often associated with opioid-based therapies.” This innovative approach is focused on addressing the underlying neural pathways responsible for chronic cough, rather than simply suppressing the symptom. The company is initially targeting chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF) and Refractory Chronic Cough (RCC), conditions for which current treatment options are limited and often ineffective.

Financial Stability Fuels Pipeline Advancement

Trevi reported $194.9 million in cash and cash equivalents as of September 30, 2025. This financial strength has allowed the company to confidently progress its clinical programs, including the planned initiation of a Phase 3 trial for chronic cough in IPF patients in the first half of 2026 and a Phase 2b trial for RCC, also slated for the first half of 2026. The company’s Q3 net loss of $11.8 million represents a slight improvement compared to the same period last year, suggesting effective cost management and strategic investment in R&D. Analysts have praised Trevi’s financial prudence and its ability to secure additional funding through a recent public offering. “The extended cash runway is a significant advantage,” stated one financial analyst. “It provides the company with the flexibility to pursue multiple clinical trials and navigate the regulatory approval process without being overly reliant on external financing.”

Positive Trial Data Supports Clinical Promise

Data presented from the Phase 2b CORAL trial (chronic cough in IPF patients) and the Phase 2a RIVER trial (refractory chronic cough) demonstrated promising reductions in cough frequency. The CORAL trial showed reductions in cough frequency ranging from 47.9% to 60.2% depending on dosage. The RIVER trial indicated a 67% reduction in cough frequency. These results were presented at major medical conferences, generating considerable excitement within the pulmonary and respiratory healthcare communities.