Rein Therapeutics Provides Clinical Trial Update for Phase 2 RENEW Study of LTI-03 in Idiopathic Pulmonary Fibrosis
Patient enrollment accelerates across expanding number of clinical trial sites in multiple countries
- 8 patients enrolled, with additional patients expected in the near term
- Enrollment initiated in March 2026, with patients being added on a regular basis
- Clinical trial sites active in the United States, Australia, and Poland, with additional countries expected to open in the near term
AUSTIN, Texas, April 29, 2026 (GLOBE NEWSWIRE) -- Rein Therapeutics ("Rein") (NASDAQ:RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today provided an update on its ongoing Phase 2 RENEW clinical trial evaluating LTI-03 for the treatment of idiopathic pulmonary fibrosis (IPF).
The Company has enrolled 8 patients in its RENEW trial to date, with 2 additional patients expected to be enrolled this week. Enrollment in the study began in March 2026, and the Company continues to add patients on a regular basis.
Rein also continues to make progress on expanding its global clinical trial footprint. Clinical trial sites are currently active in the United States, Australia, and Poland, with additional countries – including the United Kingdom and Germany – expected to open in the near term. The Company plans to continue activating more new sites to support ongoing enrollment
Brian Windsor, Ph.D., Chief Executive Officer of Rein Therapeutics, commented, "We are pleased with the progress of our Phase 2 RENEW trial, including our ongoing patient enrollment and the expansion of clinical trial sites across multiple geographies. We believe this continued execution reflects the successful efforts of our clinical teams and investigators, and we remain focused on advancing LTI-03 through development."
About the RENEW Phase 2 Trial
Rein's RENEW trial is a randomized, placebo-controlled Phase 2 clinical study designed to evaluate the safety, tolerability, and efficacy of LTI-03 in patients with idiopathic pulmonary fibrosis.
The study is expected to enroll approximately 120 patients, who will be randomized to receive one of two dose levels of LTI-03 or placebo. The major efficacy endpoint is the change from baseline in forced vital capacity (FVC), a key measure of lung function.
About LTI-03
LTI-03 is a first-in-class, inhaled peptide therapy derived from Caveolin-1 biology, a key regulator of fibrotic signaling. The drug is designed to inhibit lung scarring while preserving alveolar progenitor cells that are critical for tissue repair and regeneration.
Early data suggests that LTI-03 may represent a dual-acting approach: slowing fibrosis and promoting lung healing.
About Rein Therapeutics
Rein Therapeutics is a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Rein's lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. LTI-03 has received Orphan Drug Designation in the U.S. Rein's second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the U.S. and E.U. and Fast Track Designation in the U.S.
Forward-Looking Statements
This press release may contain forward-looking statements of Rein Therapeutics, Inc. ("Rein", the "Company", "we", "our" or "us") within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to expectations for the Company's LTI-03 product candidate. We use words such as "anticipate," "believe," "estimate," "expect," "hope," "intend," "may," "plan," "predict," "project," "target," "potential," "would," "can," "could," "should," "continue," and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: (i) the risk that the Company may not be able to successfully continue its Phase 2 clinical trials of LTI-03; (ii) the data derived from our Phase 2 clinical trials of LTI-03 may not support or validate our expectations concerning the potential benefits of LTI-03; (iii) success in early phases of pre-clinical and clinical trials do not ensure later clinical trials will be successful; (iv) the risk that the Company may not be able to obtain additional working capital with which to complete the planned clinical trials of LTI-03; and (v) those other risks disclosed in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2025, which is on file with the United States Securities and Exchange Commission (the "SEC") and in subsequent filings that the Company files with the SEC. These forward-looking statements should not be relied upon as representing the Company's view as of any date after the date of this press release, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Investor Relations
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