As of the most recent market check, shares of Trevi Therapeutics, Inc. (NASDAQ: TRVI) had increased by 36.26% to $5.86. The release of encouraging trial results, which bolstered investor confidence in the company’s treatment pipeline, is responsible for the notable increase in TRVI shares.
Positive Results from the RIVER Trial Phase 2a
Trevi Therapeutics’ Phase 2a Refractory Chronic Cough Improvement Via Nalbuphine ER (RIVER) study, which evaluated Haduvio’s effectiveness in treating Refractory Chronic Cough (RCC), produced encouraging topline findings.
In addition to demonstrating quick efficacy at the lowest dose tested, Haduvio showed advantages throughout a broad spectrum of cough severity. Furthermore, the results support the drug’s ability to treat complicated neurological cough diseases and are consistent with earlier favorable outcomes shown in chronic cough associated with idiopathic pulmonary fibrosis (IPF).
Implications for Upcoming Progress
Results from the RIVER study showed consistency across main and secondary objectives and were highly statistically significant. Significant improvements were also seen in patients with baseline cough frequencies that ranged from moderate to severe.
Trevi Therapeutics hopes to address the unmet needs of people with chronic coughs by advancing the development of nalbuphine ER in response to these results. The next study is anticipated to start with regulatory guidance, and the business intends to consult with the U.S. Food and Drug Administration (FDA) on next clinical steps.
Design and Methodology of the Trial
A randomized, double-blind, placebo-controlled, crossover research, the Phase 2a RIVER trial assessed Haduvio’s effectiveness, safety, and tolerability in treating RCC. There was a 21-day washout time in between each 21-day therapy session.
Using an objective cough monitor, the main endpoint evaluated the mean change in 24-hour cough frequency. All individuals with reliable cough count data at baseline and day 21 of at least one treatment session who had received at least one dosage of the study medication were included in the analysis.
These promising results bring Trevi Therapeutics (TRVI) one step closer to filling a major treatment gap and giving patients with incapacitating and chronic cough disorders fresh hope.