First patient dosed in Idopathic Pulmonary Fibrosis peptide Phase 2 from Rein Therapeutics

Rein Therapeutics announced that the first patient has been dosed in its Phase 2 clinical trial (called RENEW), evaluating LTI-03, a novel Caveolin-1-related peptide, designed to treat idiopathic pulmonary fibrosis (IPF). The trial aims to assess the safety, tolerability, and efficacy of LTI-03, with interim topline data expected in the first half of 2026.

LTI-03, Rein Therapeutics’ lead candidate, is a novel synthetic peptide designed to support alveolar epithelial cell survival and inhibit profibrotic signaling pathways.

The RENEW trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study. Approximately 120 patients who have been diagnosed with IPF within five years of screening will be enrolled across up to 50 global clinical sites.

Enrolled participants may also be receiving current standard-of-care (SoC) antifibrotic therapy. The primary endpoint of the trial is the incidence of treatment-emergent adverse events (TEAEs) from the first day of treatment through Week 24.

Key secondary endpoints include efficacy measures such as forced vital capacity (FVC), percent predicted FVC (ppFVC), and high-resolution computed tomography (HRCT) imaging.

Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics, stated: “We are pleased to have dosed the first patient in our RENEW Phase 2 trial of LTI-03 following 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. 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 (SoC). 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.”

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