Rein Therapeutics Starts Dosing in Phase 2 IPF Trial of LTI-03

Rein Therapeutics, a biopharmaceutical firm based in Austin, Texas, recently announced a significant milestone in its clinical research efforts. The company has initiated dosing of the first patient in its RENEW Phase 2 trial, focusing on its leading drug candidate, LTI-03, designed for treating idiopathic pulmonary fibrosis (IPF). As part of its mission to tackle fibrosis, Rein Therapeutics is advancing LTI-03, a novel peptide connected to Caveolin-1, through this rigorous clinical trial process.

The President and CEO of Rein Therapeutics, Dr. Brian Windsor, expressed satisfaction with the commencement of patient dosing in the trial, emphasizing the company's commitment to addressing fibrosis-related conditions. He highlighted the robust evidence supporting LTI-03's potential as a groundbreaking therapy for individuals suffering from IPF, a condition inadequately addressed by existing treatments. Windsor expressed gratitude towards the dedicated teams, patients, and clinical staff participating in the trial for their collective efforts in driving the project forward.

The RENEW Phase 2 trial is structured as a multi-center, randomized, double-blind, placebo-controlled study. This approach aims to thoroughly evaluate the safety, tolerability, and efficacy of LTI-03 in IPF patients. Rein Therapeutics has partnered with IQVIA, a prominent global provider specializing in clinical research services, to enhance trial enrollment efforts. The study plans to include approximately 120 patients diagnosed with IPF within five years, some of whom may be undergoing standard antifibrotic therapy. These participants will be recruited from up to 50 different sites worldwide.

The trial's primary focus is to assess the incidence of treatment-emergent adverse events (TEAEs) from the first day through the 24th week of the study. Additionally, secondary endpoints will measure the efficacy of LTI-03 through various means, including forced vital capacity (FVC), percent predicted FVC (ppFVC), and high-resolution computer tomography (HRCT). In this endeavor, Rein Therapeutics is collaborating with Qureight Ltd., leveraging their deep-learning platform to analyze the data effectively. The topline interim data from the RENEW trial is anticipated in the first half of 2026.

Rein Therapeutics positions itself as a clinical-stage biopharmaceutical enterprise focusing on the development of first-in-class therapies for underserved medical needs, particularly in orphan pulmonary and fibrosis indications. LTI-03 serves as their leading product candidate, characterized by its synthetic peptide composition and dual-action mechanism. It targets both the survival of alveolar epithelial cells and the inhibition of profibrotic signaling, aiming to offer significant therapeutic benefits to IPF patients. LTI-03 has already secured Orphan Drug Designation in the United States and is actively being evaluated in the ongoing Phase 2 RENEW trial.

In addition to LTI-03, Rein Therapeutics is advancing another promising product candidate, LTI-01. This proenzyme has completed Phase 1b and Phase 2a clinical trials for treating loculated pleural effusions. It has also been granted Orphan Drug Designation in both the United States and the European Union, along with Fast Track Designation in the U.S., reflecting its potential impact on patient care.

Rein Therapeutics continues to push the boundaries of biopharmaceutical research, striving to develop innovative treatments that address critical unmet medical needs in the realm of pulmonary and fibrotic diseases.