AUSTIN, Texas, June 11, 2026
Rein Therapeutics, Inc. (NASDAQ: RNTX) announced the expansion of its ongoing Phase 2 RENEW clinical trial evaluating LTI-03 in patients with idiopathic pulmonary fibrosis (IPF), marked by the successful randomization of the first patient in the United Kingdom. The company reported that 16 patients have been enrolled to date, with active recruitment now underway across the United States, Australia, and the United Kingdom. Rein also expects to add clinical sites in two additional countries over the coming months as it continues to broaden the international reach of the study. The expansion represents a significant step forward in the development of LTI-03, a first-in-class inhaled peptide therapy designed to address the underlying mechanisms of pulmonary fibrosis.
Global Enrollment Momentum Supports Advancement of RENEW Study
The RENEW trial is a randomized, placebo-controlled Phase 2 clinical study designed to evaluate the safety, tolerability, and efficacy of LTI-03 in patients diagnosed with idiopathic pulmonary fibrosis, a progressive and often fatal lung disease characterized by irreversible scarring of lung tissue. Rein Therapeutics plans to enroll approximately 120 patients, who will be randomized to receive one of two dose levels of LTI-03 or placebo. The primary efficacy endpoint is the change from baseline in forced vital capacity (FVC), a widely used measure of lung function and disease progression in IPF. The enrollment of the first patient in the United Kingdom highlights the company’s strategy to accelerate recruitment through international site expansion while generating robust clinical data from diverse patient populations.
LTI-03 Targets Fibrosis and Lung Regeneration Through Dual Mechanism
LTI-03 is a first-in-class inhaled peptide therapy derived from Caveolin-1 biology, a critical regulator of fibrotic signaling pathways involved in tissue scarring. Unlike conventional approaches that primarily focus on slowing disease progression, LTI-03 is designed with a dual mechanism intended to both inhibit fibrotic lung scarring and preserve alveolar progenitor cells, which play a crucial role in lung tissue repair and regeneration. Preclinical and early clinical findings suggest the therapy may offer a novel strategy capable of simultaneously reducing fibrosis while promoting healing of damaged lung tissue. This regenerative potential could differentiate LTI-03 from currently available treatments and address a significant unmet need in IPF management.
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Rein Therapeutics Advances Orphan Pulmonary Disease Pipeline
Rein Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies for orphan pulmonary and fibrotic diseases. The company’s lead candidate, LTI-03, has received Orphan Drug Designation in the United States and represents the cornerstone of its pulmonary fibrosis development strategy. Rein is also advancing LTI-01, a proenzyme therapy that has completed Phase 1b and Phase 2a studies for the treatment of loculated pleural effusions and has received Orphan Drug Designation in both the United States and European Union, along with Fast Track Designation from the FDA. With the continued expansion of the RENEW study and growing international enrollment, Rein Therapeutics is positioning itself to generate important clinical data that could support the future development of a potentially transformative treatment for patients living with idiopathic pulmonary fibrosis.
Source:Rein Therapeutics press release
