AUSTIN, Texas — 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, announced that it has dosed the first patient in its Phase 2 clinical trial evaluating LTI-03 for idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease with limited treatment options.
This milestone follows the FDA’s recent clearance to resume the Phase 2 program and reflects Rein’s successful efforts to address the Agency’s requests and advance the trial. The Phase 2 study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, tolerability, and impact to lung function and structure of LTI-03, an inhaled therapy intended to regulate multiple fibrosis pathways and preserve lung function.
The study will enroll approximately 120 patients across placebo, low dose, and high dose groups at clinical sites in five countries. In addition to safety and tolerability, the trial will closely monitor changes in lung function, including forced vital capacity (FVC), a key tool in the measurement of respiratory health in patients with IPF.
Rein expects to enroll patients through mid-2027, with interim data anticipated in the second half of 2026.
Brian Windsor, Ph.D., Chief Executive Officer of Rein Therapeutics, commented, “Dosing the first patient in this Phase 2 trial marks an important step forward for Rein and, more importantly, for patients living with IPF. Current therapies offer limited benefit and often come with significant side effects. Our goal with LTI-03 is to go beyond slowing disease progression and help preserve lung function by addressing the underlying biology of fibrosis. This milestone reflects our team’s focus on execution and brings us closer to understanding the potential impact of LTI-03 for patients.”
The trial is currently active at five clinical sites in the United States, with more sites expected to open in the coming months. Rein plans to expand to up to 50 sites as enrollment progresses.
Idiopathic pulmonary fibrosis affects approximately 100,000 people in the United States each year and is characterized by scarring of lung tissue, leading to progressive loss of lung function and a median survival of three to five years from diagnosis.
LTI-03 is designed to mimic the activity of Caveolin-1, a cell associated protein that plays a role in regulating normal tissue function and repair. By modulating multiple fibrotic pathways and supporting the health of alveolar epithelial progenitor cells, LTI-03 aims to address the underlying drivers of fibrosis rather than targeting a single pathway.
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. 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. For more information please visit https://www.reintx.com/.
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