Tvardi Therapeutics Faces Setback as Lung Disease Trial Fails
Tvardi Therapeutics Stock Update
Tvardi Therapeutics Inc. (NASDAQ: TVRD) experienced a significant decline in its stock price following disappointing news regarding its Phase 2 clinical trial data. The company observed a session trading volume that peaked at more than 5.5 million shares, notable compared to the average volume of roughly 42,000 shares.
Phase 2 REVERT Trial Overview
The preliminary data from the Phase 2 REVERT trial aimed at testing TTI-101, alone or combined with nintedanib (OFEV), for patients suffering from idiopathic pulmonary fibrosis (IPF) was not promising. Upon assessment of both safety and efficacy results related to Forced Vital Capacity (FVC) levels, Tvardi Therapeutics concluded that the trial did not meet its set objectives.
Understanding the Clinical Results
Some key observations from the trial indicated a similarity in baseline characteristics among patients across treatment groups. However, those receiving a placebo exhibited a lower predicted FVC percentage at 70.1%, markedly below the 74.1% and 81.1% levels noted in the TTI-101 groups.
Difficulties in Discontinuation Rates
The trial's discontinuation rates presented a discrepancy that raised concerns. The placebo group had a lower discontinuation rate at 10.3%, contrasted sharply with the higher rates in the groups receiving the drug (56.7% for 400mg and 62.1% for 800mg). Most discontinuations in the TTI-101 arm were attributed to gastrointestinal side effects, particularly in participants also taking nintedanib.
Assessing Efficacy and Future Directions
It's crucial to note that the trial was not statistically powered to assess exploratory endpoints adequately. The number of patients eligible to evaluate efficacy shrunk over time, with significant reductions in counted patients by the 12-week mark. Despite hoped-for improvements, the exploratory efficacy analysis indicated no statistically significant differences between the treatment and placebo groups, and the variance within treatment arms was substantial.
Executive Insights on Future Prospects
Imran Alibhai, CEO of Tvardi, expressed that the findings from the TTI-101 IPF study could not demonstrate a clear benefit at this point. He cited the limited dataset and unexpected results from the placebo group as hurdles hindering definitive conclusions. The company is currently undertaking further analyses to glean deeper insights.
Upcoming Announcements and Financial Health
Looking forward, Tvardi Therapeutics anticipates sharing topline preliminary data in the first half of 2026 regarding a separate healthy volunteer study involving TTI-109, in addition to a Phase 2 trial concerning TTI-101 for hepatocellular carcinoma. As of the latter half of 2025, the company had reported approximately $41 million in liquid assets, which is expected to support operations into late 2026.
Current Stock Performance
Price Action: The stock was trading significantly lower at $6.58 per share at the time of this update, marking an 84.18% decrease and approaching its 52-week low.
Frequently Asked Questions
What are the main findings from the Phase 2 REVERT trial?
The Phase 2 REVERT trial for TTI-101 showed no statistical benefit over the placebo, with high discontinuation rates in treatment arms due to adverse effects.
How did the stock react to the trial results?
Tvardi's stock dropped 84.18% to $6.58 immediately following the announcement of disappointing trial data.
What factors contributed to the trial's disappointing results?
The trial faced issues with high variability in treatment responses and a higher-than-expected placebo response, complicating the evaluation of TTI-101's efficacy.
What is the company's financial outlook?
Tvardi reported $41 million in cash reserves, projected to sustain its operations through the fourth quarter of 2026.
What future trials are being planned by Tvardi Therapeutics?
The company is planning to present topline results from a healthy volunteer trial of TTI-109 and a Phase 2 trial exploring TTI-101 for liver cancer.
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