Rein Therapeutics Receives European Regulatory Approval to Initiate Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis

• EMA approval covers study sites in Germany and Poland as part of the Company’s global Phase 2 RENEW trial
• Trial will evaluate LTI-03, a first-in-class therapy designed to both reduce lung scarring and promote repair

AUSTIN, Texas, Oct. 09, 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 that it has received authorization from the European Medicines Agency (EMA) to initiate the Company’s Phase 2 “RENEW” clinical trial of its lead candidate, LTI-03, for the treatment of idiopathic pulmonary fibrosis (IPF).

The approvals cover clinical trial sites in Germany and Poland, which will serve as key European centers for the global study. Rein has already received regulatory clearance from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA).

Brian Windsor, Chief Executive Officer of Rein Therapeutics, commented, “These new authorizations mark another important milestone in our global RENEW trial. With approvals now in the U.K., Germany, and Poland, we are well positioned to begin enrolling patients in multiple regions and advance LTI-03 toward our goal of redefining how pulmonary fibrosis is treated. We are grateful to our clinical partners across Europe for their collaboration and commitment to improving outcomes for patients with IPF.”

About the RENEW Trial

The RENEW trial is a randomized, double-blind, placebo-controlled Phase 2 study evaluating the safety, tolerability, and efficacy of LTI-03 in patients with IPF. The study will enroll up to 120 patients globally, with a treatment duration of 24 weeks across two dosing groups.

Key secondary endpoints include changes in lung function (FVC) and imaging-based assessments of fibrosis progression.

LTI-03 is a Caveolin-1–derived peptide designed to both inhibit fibrosis and support regeneration of healthy lung tissue by protecting alveolar progenitor cells that are critical for repair.

About Idiopathic Pulmonary Fibrosis (IPF)

IPF is a chronic, progressive lung disease characterized by irreversible scarring that makes it increasingly difficult for patients to breathe. Median survival is 3–5 years after diagnosis, even with currently approved therapies, which primarily aim to slow disease progression rather than restore lung function.