Trevi Therapeutics (NASDAQ:TRVI), Inc. has announced significant milestones in its clinical development programs, according to a recent SEC filing. The biopharmaceutical company, focused on pharmaceutical preparations, shared updates on several ongoing trials on Thursday.
The company's Phase 2b CORAL trial, aimed at treating chronic cough in idiopathic pulmonary fibrosis patients, has reached 50% of its enrollment target necessary for a sample size re-estimation (SSRE). This re-estimation is scheduled after the last participant completes six weeks of treatment, with results expected in December 2024.
Depending on the SSRE, the trial may maintain its current sample size of 160 patients, adjust the number, or evaluate for futility. Topline results from the trial are anticipated in the first half of 2025, assuming no changes to the sample size.
Moreover, Trevi has completed dosing in its Human Abuse Potential study, with topline results also expected in December 2024. The Phase 2a RIVER trial, which focuses on refractory chronic cough treatment, has reached its planned sample size. However, enrollment remains open to better match stratification targets. The company now expects topline results for this trial in the first quarter of 2025.
These forward-looking statements, including the anticipated timelines and outcomes of the clinical trials, are subject to risks and uncertainties. Factors such as trial success, regulatory authorities' opinions, and financial conditions could affect the actual results, which may differ from the current expectations.
The company, which is classified as an emerging growth company, continues to follow its strategic plan for Haduvio, its product candidate, and other clinical trials. Trevi Therapeutics is headquartered in New Haven, Connecticut, and trades on The Nasdaq Stock Market LLC under the symbol NASDAQ:TRVI. The information in this article is based on a press release statement filed with the SEC.
In other recent news, Trevi Therapeutics has made substantial progress in its clinical trials for Haduvio™, a treatment 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, and the Human Abuse Potential (HAP) study has completed dosing. The Phase 2a RIVER trial for RCC has met its planned sample size, with top-line results expected in early 2025.
Analyst firms Raymond James, H.C. Wainwright, and EF Hutton have initiated coverage on Trevi Therapeutics, with Raymond James and H.C. Wainwright assigning an Outperform and Buy rating respectively. EF Hutton has given a Buy rating, influenced by promising clinical data suggesting a reduced risk for the ongoing trials.
Despite a reported net loss of $12.4 million in its Second Quarter 2024 Earnings Conference Call, Trevi Therapeutics, with funding secured until 2026, continues to advance several trials. The RIVER trial for RCC is 80% enrolled, with key data expected by the end of 2024, and the CORAL Phase 2b trial for IPF chronic cough is actively enrolling, with top-line data anticipated in the first half of 2025. These recent developments underscore the potential market opportunity for Trevi Therapeutics' Haduvio.
InvestingPro Insights
Trevi Therapeutics' recent clinical milestones come amid some financial challenges, as highlighted by InvestingPro data. The company's stock has taken a significant hit over the last week, reflecting market reactions to its ongoing clinical trials and financial position. InvestingPro Tips reveal that Trevi is not profitable over the last twelve months, and analysts do not anticipate the company will be profitable this year. This aligns with the company's focus on clinical development and the extended timelines for trial results mentioned in the article.
On a positive note, Trevi holds more cash than debt on its balance sheet, and its liquid assets exceed short-term obligations. These factors could provide some financial stability as the company progresses through its clinical trials, particularly the Phase 2b CORAL trial and the Phase 2a RIVER trial, which are not expected to yield results until late 2024 and early 2025, respectively.
For investors seeking a more comprehensive analysis, InvestingPro offers 7 additional tips for Trevi Therapeutics, providing deeper insights into the company's financial health and market position.
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