Trevi Therapeutics: A Milestone in Refractory Chronic Cough Treatment

Trevi Therapeutics, a clinical-stage biopharmaceutical company, has recently announced the completion of enrollment for its Phase 2a RIVER trial in refractory chronic cough (RCC). This significant milestone brings hope to the millions of patients worldwide suffering from this debilitating condition, for which there are currently no approved treatments.

Refractory chronic cough, defined as a persistent cough lasting more than eight weeks despite treatment for an underlying condition or where no underlying condition exists, affects approximately 2-3 million patients in the United States alone. The condition is highly disruptive, causing social embarrassment, sleep disruption, and significant economic burdens for patients and those around them.

Trevi Therapeutics' investigational therapy, Haduvio™ (oral nalbuphine extended-release), acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA). This unique mechanism of action has the potential to provide relief for patients suffering from RCC.

The Phase 2a RIVER trial is a randomized, double-blind, placebo-controlled, two-treatment, two-period, crossover study designed to evaluate the efficacy, safety, tolerability, and dosing of Haduvio for the treatment of RCC. The trial is being conducted at multiple sites in the United Kingdom and Canada, with approximately 60 adult patients enrolled.

The primary endpoint of the trial is a mean change in 24-hour cough frequency in the overall population, as determined using an objective cough monitor. The trial will also explore secondary endpoints, including patient-reported outcome measures for cough frequency and severity. The results of this trial are expected to provide valuable insights into the potential of Haduvio as a treatment for RCC.

The completion of enrollment in the Phase 2a RIVER trial is a significant step forward in the development of Haduvio as a potential treatment for refractory chronic cough. The results of this trial are eagerly anticipated by patients, healthcare professionals, and investors alike, as they could pave the way for a new treatment option for this challenging condition.

In addition to the RIVER trial, Trevi Therapeutics is also conducting a Phase 2b clinical trial for idiopathic pulmonary fibrosis (IPF) patients with chronic cough, called CORAL. This trial is expected to provide further insights into the potential of Haduvio as a treatment for chronic cough in IPF patients.

The success of Trevi Therapeutics' clinical development programs, including the RIVER trial, could have a significant impact on the market perception and valuation of the company. Positive data from these trials could pave the way for regulatory approval and commercialization of Haduvio, potentially transforming the treatment landscape for chronic cough in both IPF and RCC patients.

In conclusion, the completion of enrollment in the Phase 2a RIVER trial is a significant milestone for Trevi Therapeutics and the millions of patients suffering from refractory chronic cough. The results of this trial are eagerly anticipated, as they could provide a much-needed treatment option for this challenging condition. As Trevi Therapeutics continues to advance its clinical development programs, investors should closely monitor the progress of these trials, as they could have a significant impact on the company's future.