Austin, Texas, USA | July 21, 2026
Rein Therapeutics announced that its Phase 2 RENEW clinical trial evaluating the investigational therapy LTI-03 for idiopathic pulmonary fibrosis (IPF) is now actively enrolling patients across all five planned countries, following the addition of Germany to the ongoing international study. Germany joins the United States, United Kingdom, Australia, and Poland, completing the trial’s global expansion strategy and increasing the number of active clinical sites available for patient recruitment. The milestone is particularly important for IPF research, where identifying eligible participants can be challenging due to the rarity and complexity of the disease. Rein Therapeutics remains on schedule to report initial topline Phase 2 data during the second half of 2026, marking an important step in the clinical development of its first-in-class inhaled peptide therapy designed to treat one of the most serious progressive fibrotic lung disorders.
Phase 2 RENEW Trial Evaluates Safety and Lung Function Improvements
The RENEW Phase 2 trial is a randomized, placebo-controlled clinical study designed to evaluate the safety, tolerability, and efficacy of LTI-03 in approximately 120 patients diagnosed with idiopathic pulmonary fibrosis. Participants are being randomized to receive one of two dose levels of inhaled LTI-03 or placebo, allowing investigators to assess both dose response and therapeutic benefit. The study’s primary efficacy endpoint is the change from baseline in forced vital capacity (FVC), a widely accepted clinical measure of lung function and disease progression in patients with pulmonary fibrosis. Expanding recruitment across five countries is expected to accelerate enrollment while improving access for eligible patients seeking investigational treatment options for this debilitating and life-threatening rare disease.
LTI-03 Targets Fibrosis While Supporting Lung Tissue Repair
LTI-03 is a first-in-class inhaled synthetic peptide therapy derived from Caveolin-1 biology, a critical regulator of fibrotic signaling pathways involved in progressive lung scarring. Unlike conventional treatment approaches, LTI-03 is designed with a dual mechanism of action, simultaneously inhibiting fibrotic tissue formation while preserving alveolar progenitor cells, which play an essential role in repairing and regenerating damaged lung tissue. This differentiated approach aims not only to slow disease progression but also to promote restoration of healthy lung function. Supporting its clinical development, positive Phase 1b clinical data for LTI-03 were recently published in the peer-reviewed journal Nature Communications, providing additional scientific validation for the therapy’s potential in treating idiopathic pulmonary fibrosis..
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Global Expansion Strengthens Rein Therapeutics’ Fibrosis Pipeline
According to Brian Windsor, Ph.D., Chief Executive Officer of Rein Therapeutics, opening enrollment across all five participating countries represents an important operational milestone that expands patient access while strengthening execution of the company’s global clinical strategy. Germany’s inclusion is particularly significant because of its established leadership in pulmonary fibrosis research and extensive network of specialized treatment centers. Beyond LTI-03, Rein Therapeutics continues advancing a broader pipeline of first-in-class therapies for orphan pulmonary and fibrosis-related diseases, including LTI-01, a proenzyme therapy that has completed Phase 1b and Phase 2a clinical studies for loculated pleural effusions and has received Orphan Drug Designation in both the United States and European Union, as well as FDA Fast Track Designation. With global enrollment now fully established and topline data anticipated later this year, Rein Therapeutics continues to strengthen its position in developing innovative therapies for patients with serious rare pulmonary diseases and significant unmet medical needs
Source: Rein Therapeutics press release
