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TVRD 資訊
TVRD 事件
Tvardi Therapeutics Selects Ulcerative Colitis as Initial Indication for TTI-109
Tvardi Therapeutics announced that it has selected ulcerative colitis as the initial disease indication for its next generation STAT3 inhibitor, TTI-109. Tvardi plans to initiate a study of TTI-109 in patients with moderate-to-severe UC in 2027, subject to clearance of Investigational New Drug application and additional funding. The primary endpoint will be safety, and the secondary endpoint will be clinical remission at 12 weeks. Tvardi will host a Key Opinion Leader webinar featuring Randy Longman of Weill Cornell Medicine on Wednesday, August 19, at 11:00 a.m. ET.
Tvardi Therapeutics Reports Phase 1 Results for TTI-109 with Improved Tolerability
Tvardi Therapeutics announced results from its Phase 1 study of TTI-109, its next-generation STAT3 inhibitor. The study confirmed that TTI-109, designed as a prodrug of TTI-101, rapidly converted to the parent compound within two hours and demonstrated equivalent drug exposure with improved tolerability, including shorter-duration diarrhea events. Exploratory data also showed up to a 60% reduction in disease-relevant immune cell populations. Tvardi plans to advance the candidate into Phase 2 development for dermatologic and gastrointestinal diseases, pending regulatory clearance and funding. "These Phase 1 results validate our prodrug strategy on every objective we set out to test. TTI-109 matched TTI-101's exposure at molar-equivalent doses with substantially better tolerability and delivered a pharmacodynamic signal across disease-relevant immune cell populations that we would not typically expect to see in healthy volunteers. That combination of findings supports our development pathway into Phase 2," said Imran Alibhai, CEO of Tvardi.
Tvardi CEO Expects TTI-109 Data to Inform Clinical Strategy
Imran Alibhai, Chief Executive Officer of Tvardi, stated, "We are approaching a key inflection point with topline data from our next-generation STAT3 inhibitor, TTI-109, expected in June. These results are expected to inform our future clinical development strategy."
Tvardi Therapeutics Files $200M Mixed Securities Shelf
Tvardi Therapeutics files $200M mixed securities shelf
Tvardi Cash Reserves at $30.8M, Sufficient to Fund Operations Through Q4 2026
Cash, cash equivalents and short-term investments as of December 31, 2025, were $30.8M, as compared to $31.6M as of December 31, 2024. Tvardi anticipates that its current cash runway is sufficient to fund operations, as currently planned, through clinical readouts and into the fourth quarter of 2026. Imran Alibhai, CEO of Tvardi, stated, "We entered 2026 with line-of-site to two significant clinical milestones: 1) healthy volunteer data from our next-generation STAT3 inhibitor, TTI-109, in the second quarter of this year, and 2) topline data from our ongoing Phase 2 trial of TTI-101 in HCC, which we anticipate in the second half."
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