Rein Therapeutics Announces First Patient Dosed in Phase 2 Trial of LTI-03 in Patients With IPF

Rein Therapeutics recently announced the first patient has been dosed in the RENEW Phase 2 trial of its lead asset, LTI-03, a novel, multi-pathway, Caveolin-1-related peptide for the treatment of idiopathic pulmonary fibrosis (IPF).

“We are pleased to have dosed the first patient in our RENEW Phase 2 trial of LTI-03 following the swift initiation of the trial. We are profoundly focused on our mission to rein in fibrosis and look forward to continuing our momentum in the clinic,” said Brian Windsor, PhD, President and Chief Executive Officer of Rein Therapeutics. “We are encouraged by the strong body of evidence supporting LTI-03 as a potentially innovative treatment for patients with IPF whose needs are unmet by the current standard of care. I am grateful to our team at Rein, the patients, investigators, and staff participating in our trial for the efficient progress that we are making.”

The RENEW trial is a Phase 2 multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of LTI-03 in patients with IPF. Rein is collaborating with IQVIA (NYSE: IQV), a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries, on enrollment for the trial. RENEW will enroll approximately 120 patients diagnosed with IPF within 5 years of screening, who may be receiving standard of care (SoC) antifibrotic therapy, across up to 50 sites globally. The primary endpoint for the trial is the incidence of treatment-emergent adverse events (TEAEs) from Day 1 through Week 24. The key secondary endpoint is the efficacy of LTI-03 measured through forced vital capacity (FVC), percent predicted FVC (ppFVC), and high-resolution computer tomography (HRCT), in collaboration with Qureight Ltd. Topline interim data from RENEW is expected in the first half of 2026.

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 US and is currently being evaluated in a Phase 2 trial, titled the RENEW trial, in patients with idiopathic pulmonary fibrosis. 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 US and EU and Fast Track Designation in the US. For more information, visit reintx.com.