Rein Therapeutics Announces Phase 2 RENEW Trial Now Enrolling Across All Five Countries
Rhea-AI Summary
Rein Therapeutics (NASDAQ: RNTX) reported that its randomized, placebo-controlled Phase 2 RENEW trial of inhaled LTI-03 in idiopathic pulmonary fibrosis is now open and enrolling across all five planned countries: the United States, United Kingdom, Australia, Poland, and newly added Germany, with a target of about 120 patients.
The study evaluates two dose levels of LTI-03 versus placebo, with change from baseline in forced vital capacity (FVC) as the major efficacy endpoint. According to Rein Therapeutics, enrollment is progressing and initial topline data are expected in the second half of 2026. LTI-03 is a first-in-class, inhaled peptide derived from Caveolin-1 biology, designed to inhibit lung scarring while preserving alveolar progenitor cells. Early data from a Phase 1b study have been published in Nature Communications. The company also highlights LTI-03’s U.S. Orphan Drug Designation and its second candidate, LTI-01, which has completed Phase 1b and Phase 2a trials and holds orphan and Fast Track designations.
Positive
- RENEW Phase 2 fully opened in five countries, including Germany, expanding enrollment sites for IPF
- Approximately 120 IPF patients planned for randomized, placebo-controlled evaluation of inhaled LTI-03
- Topline Phase 2 data expected in 2H 2026, providing a defined clinical readout timeline
- LTI-03 characterized as first-in-class inhaled peptide with dual fibrosis and repair mechanism
- Phase 1b LTI-03 data already published in peer-reviewed journal Nature Communications
- LTI-03 and LTI-01 both hold Orphan Drug Designation; LTI-01 also has U.S. Fast Track status
Negative
- None.
Market reaction after Phase 2 trial enrollment: RNTX +6.02% in the Jul 21 session
In the Jul 21 session, RNTX gained 6.02%, reflecting a notable positive market reaction. Argus tracked a peak move of +6.0% during that session. Argus tracked a trough of -5.5% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 11 | Phase 2 expansion | Positive | +0.6% | United Kingdom enrollment expanded RENEW's international clinical footprint. |
| Apr 29 | Trial enrollment update | Positive | -12.1% | RENEW enrollment began with additional patients expected and country expansion planned. |
| Mar 03 | Phase 2 initiation | Positive | -3.4% | First patient was dosed after FDA clearance to resume the program. |
| Jan 20 | Orphan designation | Positive | -0.8% | European Commission granted orphan drug designation to LTI-03 for IPF. |
| Oct 09 | Regulatory authorization | Positive | -1.4% | EMA authorized German and Polish sites for the global Phase 2 RENEW trial. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-matched clinical-trial events averaged a -3.43% move, with four of five events diverging from their positive operational or regulatory news.
Key Terms
idiopathic pulmonary fibrosis medical
placebo-controlled medical
forced vital capacity (FVC) medical
alveolar progenitor cells medical
orphan drug designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
- 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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