Rein Therapeutics Announces Phase 2 RENEW Trial Now Enrolling Across All Five Countries
- Global Expansion Complete as Germany Joins Ongoing Study of Inhaled LTI-03 in Idiopathic Pulmonary Fibrosis
- Company on track to report initial topline data in 2H 2026
AUSTIN, Texas, July 21, 2026 (GLOBE NEWSWIRE) — Rein Therapeutics, Inc. (“Rein” or the “Company”) (NASDAQ: RNTX), a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class medicines for orphan pulmonary and fibrosis indications, today announced that its Phase 2 RENEW clinical trial is now open and enrolling patients across all five planned countries, with Germany joining the United States, United Kingdom, Australia, and Poland.
The RENEW study is a randomized, placebo-controlled Phase 2 trial evaluating inhaled LTI-03 in approximately 120 patients with idiopathic pulmonary fibrosis (IPF). Completing the planned country expansion increases the number of active sites available to identify eligible patients, an important factor in a disease where the number of trial-eligible patients at any single center is limited.
Brian Windsor, Ph.D., Chief Executive Officer of Rein Therapeutics, commented, “Opening all five countries is an important operational milestone for our RENEW program. Enrollment continues to progress well across our active sites, and expanding into Germany, one of the leading centers for pulmonary fibrosis research in Europe, gives more patients the opportunity to participate. We remain focused on executing the trial, generating high-quality clinical data, and reporting initial topline data in 2H 2026.”
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.
(ClinicalTrials.gov: NCT06968845)
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.
Clinical data from the Phase 1b study of LTI-03 were recently published in the peer-reviewed journal Nature Communications.
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.
Cautionary Note Regarding 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 and LTI-01 product candidates. 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; and (iv) 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 filed with the SEC on March 26, 2026, and in subsequent filings that the Company makes with the SEC. These forward-looking statements should not be relied upon as representing the Company’s views as of any date after the date of this press release, and the Company expressly disclaims 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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