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Rein Therapeutics Announces Publication of New Translational Data in iScience on Company’s Novel Therapy for Idiopathic Pulmonary Fibrosis

Key Takeaway: Rein Therapeutics announced the publication of new data on its drug candidate LTI-03, demonstrating anti-fibrotic activity in lung tissue from IPF patients. The findings support the ongoing Phase 2 RENEW trial, which aims to evaluate LTI-03's safety and efficacy. The urgent need for effective treatments in IPF is emphasized by the disease's high mortality rate and limited current options.
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Market Sentiment Analysis

POSITIVE FACTORS

  • LTI-03 shows potential anti-fibrotic effects in IPF lung tissue.
  • Peer-reviewed publication validates LTI-03's efficacy.
  • Phase 2 RENEW trial is underway to evaluate LTI-03 in IPF patients.
  • Urgent need for effective IPF treatments highlighted by market potential.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~14 mo
Low dilution risk
Lead asset
Nivolumab
Phase 3 · Metastatic Kidney Cancer

Full Press Release Details

AUSTIN, Texas, Sept. 17, 2025 (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 announced the publication of novel data on its lead drug candidate, LTI-03, in iScience, a peer-reviewed, open-access journal published by Cell Press.
The paper, titled “LTI-03 peptide demonstrates anti-fibrotic activity in ex vivo lung slices from IPF patients,” reports how LTI-03 was tested directly on lung tissue donated by patients with idiopathic pulmonary fibrosis (IPF) who underwent lung transplant. In this model, LTI-03 showed signs of reducing scarring and protecting lung cells, reinforcing its potential as an important new therapy.

Key Highlights

Brian Windsor, PhD, Chief Executive Officer of Rein Therapeutics, commented, “Using a highly relevant translational model, this peer-reviewed publication provides further validation of LTI-03’s broad anti-fibrotic effects in IPF lung tissue. These data support our ongoing Phase 2 RENEW trial, where we are evaluating LTI-03 in patients living with IPF, a disease with very limited treatment options and high unmet need.”

Urgent Need

IPF is a progressive fibrotic lung disease that affects approximately 100,000 people in the U.S. and more than 70,000 in the U.K. Median survival is just 3–5 years from diagnosis, even with currently approved therapies. The global market for IPF treatments is projected to exceed $11 billion by 2031, underscoring the urgent need for more effective approaches.

Next Steps

Rein recently announced regulatory approval from the U.K.’s MHRA to initiate the Phase 2 RENEW trial of LTI-03. The trial will evaluate safety, tolerability, and changes in lung function in up to 120 patients, with initial data expected in 2026.
The full article can be found here:

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. and is in clinical development. 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 as well as the risks disclosed in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2024, 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.

Rein Investor Relations & Media Contact:

Frequently Asked Questions

What is LTI-03?

LTI-03 is a novel synthetic peptide developed by Rein Therapeutics targeting idiopathic pulmonary fibrosis.

What does the new publication reveal?

The publication shows LTI-03's anti-fibrotic activity in lung tissue from IPF patients.

What is the Phase 2 RENEW trial?

The Phase 2 RENEW trial evaluates the safety and efficacy of LTI-03 in IPF patients.

Why is there a need for new IPF treatments?

IPF has a high mortality rate and limited treatment options, highlighting the urgent need for effective therapies.

What is the market potential for IPF treatments?

The global market for IPF treatments is projected to exceed $11 billion by 2031.

Last updated: Sep 17, 2025