NEW HAVEN, Conn. - Trevi Therapeutics, Inc. (NASDAQ:TRVI), a clinical-stage biopharmaceutical company, has announced significant progress in its ongoing clinical trials for Haduvio™, the company's investigational therapy for chronic cough due to idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). The Phase 2b CORAL trial has reached 50% of its targeted enrollment, a critical step towards a sample size re-estimation slated for December 2024.
The CORAL trial evaluates the efficacy of Haduvio™, an extended-release oral formulation of nalbuphine, designed to act on both central and peripheral pathways in the cough reflex arc. The company anticipates that the sample size re-estimation (SSRE) will determine whether the current sample size of 160 participants will be maintained, increased within a pre-set range, or evaluated for futility. If no adjustments are made, top-line results from the trial are expected in the first half of 2025.
Additionally, Trevi reported the completion of dosing in its Human Abuse Potential (HAP) study, with top-line results also expected in December 2024. This study is part of the regulatory requirements to assess the abuse potential of new drugs with central nervous system activity.
The Phase 2a RIVER trial for RCC has met its planned sample size, though enrollment remains open to better match stratification targets. Top-line results for this trial are now projected for the first quarter of 2025.
Trevi Therapeutics is focused on addressing the unmet medical needs in chronic cough, a condition that significantly affects patients' quality of life and may lead to disease progression or increased mortality in IPF. Currently, there are no approved treatments for chronic cough in IPF or RCC in the United States, highlighting the potential impact of Haduvio™ if proven effective.
As the trials continue, the company emphasizes that the safety and efficacy of Haduvio™ have not been established by any regulatory authority. The information in this article is based on a press release statement from Trevi Therapeutics.
In other recent news, Trevi Therapeutics has made significant strides in the development of Haduvio, a treatment for chronic cough in idiopathic pulmonary fibrosis (IPF) patients and refractory chronic cough (RCC). Raymond James recently initiated coverage of Trevi Therapeutics with an Outperform rating, highlighting the potential of Haduvio in addressing these conditions. The company reported a net loss of $12.4 million in its Second Quarter 2024 Earnings Conference Call, but with funding secured until 2026, it continues to advance several trials.
The RIVER trial for RCC is 80% enrolled, with key data expected by the end of 2024. The CORAL Phase 2b trial for IPF chronic cough is also actively enrolling, with topline data anticipated in the first half of 2025. Analyst firms H.C. Wainwright and EF Hutton have also initiated coverage on Trevi Therapeutics with a Buy rating, influenced by promising clinical data that suggests a reduced risk for the ongoing trials.
These recent developments underscore the potential market opportunity for Trevi Therapeutics' Haduvio. As the pharmaceutical industry continually seeks solutions for conditions with unmet needs, Trevi's progress and potential success in this niche could be a significant development for the company and its shareholders.
InvestingPro Insights
As Trevi Therapeutics (NASDAQ:TRVI) advances its clinical trials for Haduvio™, investors may find value in examining the company's financial health and market performance. According to InvestingPro data, Trevi's market capitalization stands at $219.95 million, reflecting the market's current valuation of the company's potential.
Despite the promising progress in its clinical trials, it's important to note that Trevi is currently not profitable. An InvestingPro Tip indicates that the company has been "quickly burning through cash," which is not uncommon for clinical-stage biopharmaceutical companies investing heavily in research and development. This cash burn rate underscores the importance of the ongoing trials' success for Trevi's future financial stability.
On a positive note, another InvestingPro Tip reveals that Trevi "holds more cash than debt on its balance sheet," suggesting a degree of financial flexibility as it pursues its clinical objectives. This liquidity position could be crucial in supporting the company through the completion of its trials and potential commercialization phases.
Interestingly, Trevi has shown strong market performance, with a year-to-date price total return of 138.06% as of the latest data. This significant increase may reflect investor optimism about the company's pipeline and the potential market for Haduvio™, particularly given the unmet medical needs in chronic cough treatment that Trevi aims to address.
For investors seeking a more comprehensive analysis, InvestingPro offers additional tips and metrics that could provide deeper insights into Trevi's financial position and market prospects. Currently, there are 10 additional InvestingPro Tips available for Trevi Therapeutics, which could be valuable for those looking to make informed investment decisions in the biopharmaceutical sector.
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