Rein Therapeutics recently announced 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.”

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.

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.

According to the National Institutes of Health (NIH), IPF has an estimated prevalence of 13 to 20 per 100,000 people worldwide. In just the United States alone, about 100,000 people have IPF, and approximately 30,000 to 40,000 new cases are diagnosed each year.

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.