Full Press Release Details
Tvardi Therapeutics Announces Completion of
Phase 2 Clinical Trial of TTI-101 in Idiopathic
Topline data from the REVERTIPF trial
anticipated in 4Q 2025
HOUSTON, TX - May 27, 2025 - Tvardi Therapeutics, Inc.
("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule
therapies targeting STAT3 to treat fibrosis-driven diseases, today announced that it has completed enrollment for its lead program in
a Phase 2 clinical trial of TTI-101 for patients with idiopathic pulmonary fibrosis (IPF). The REVERT IPF Phase 2 clinical trial is a
randomized, double-blind, placebo-controlled clinical trial of TTI-101 in patients suffering from IPF. Key endpoints include safety and
lung function (FVC).
TTI-101, is an oral, small molecule inhibitor of STAT3. STAT3 is a
central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression.
IPF is a chronic, progressive, and debilitating lung disease with unknown
etiology. Patients diagnosed with IPF have a poor prognosis, with most patients experiencing worsening respiratory symptoms, declining
lung function, and functional impairment. Although several ongoing efforts are underway to discover novel ways to treat IPF, none have
interrogated STAT3. STAT3 plays a critical role as a central mediator underlying the pathogenesis of fibrosis in IPF.
Alibhai, Chief Executive Officer of Tvardi, stated, "We are thrilled to announce the completion of enrollment in our Phase 2 trial
of TTI-101 for idiopathic pulmonary fibrosis, our lead clinical indication. This marks a major milestone in our mission to address a disease
with high unmet need-where current therapies only slow progression
but fall short of halting or reversing fibrosis. TTI-101 has demonstrated a unique and powerful dual mechanism of action: inhibiting STAT3-driven
proliferation while activating T-cells, resulting in reduced lung fibrosis and restored lung function in preclinical studies. We are energized
by the potential of TTI-101 and are eager to see whether the preclinical studies' results translate into our Phase 2 REVERT IPF
trial. Topline data is expected in Q4 of this year."
About Tvardi Therapeutics
Tvardi is a clinical-stage biopharmaceutical
company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant
unmet need. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation,
survival and immune suppression. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and
immune evasion of cancer cells. The company is conducting Phase 2 clinical trials in fibrosis-driven diseases with high unmet need: idiopathic
pulmonary fibrosis (NCT05671835) and hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com
Cautionary Statement Regarding Forward-looking Statements
Statements contained in this press release regarding matters that are
not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of
1995. Words such as "will," "anticipate," "potential," or other words that convey uncertainty of future
events or outcomes to identify these forward-looking statements. Examples of these forward-looking statements include statements concerning
the anticipated benefits of Tvardi's product candidates; its ongoing clinical trials, including the expected timing for topline
data readouts; and other statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future,
and, therefore, you are cautioned not to place undue reliance on them.
Because such statements are subject to risks and uncertainties, actual
results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are
subject to a number of risks, including, among other things: the uncertainties associated with Tvardi's product candidates, as well
as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion
of clinical trials; preclinical results may not be indicative of results that may be observed in clinical trials; the significant net
losses Tvardi has incurred since inception; Tvardi's ability to initiate and complete ongoing and planned preclinical studies and
clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi's
clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi's product candidates, including the ability
of those trials to satisfy relevant governmental or regulatory requirements; Tvardi's plans to research, develop and commercialize
its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi's product candidates;
the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms
or at all; Tvardi's ability to attract, hire, and retain skilled executive officers and employees; Tvardi's ability to protect
its intellectual property and proprietary technologies; Tvardi's reliance on third parties, contract manufacturers, and contract
research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks
associated with changes in applicable laws or regulations; those factors discussed in Tvardi's filings with the Securities and Exchange
Commission, including the "Risk Factors" section of the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025,
filed with the Securities and Exchange Commission (the "SEC") on May 13, 2025, and Tvardi's other documents subsequently
filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which
they were made. The combined company undertakes no obligation to update such statements to reflect events that occur or circumstances
that exist after the date on which they were made, except as required by law.