Rein Therapeutics Begins Phase 2 RENEW Trial of LTI-03 for IPF

Rein Therapeutics (Rein), 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 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), has been initiated with screening and recruitment of patients underway.

""The initiation of the RENEW trial in patients with IPF marks a significant step forward for Rein as we prepare to ultimately identify and share the potential benefits of LTI-03 on patient lung function,"" said Brian Windsor, Ph.D., president and chief executive officer of Rein Therapeutics. ""Following productive FDA interactions and positive topline results from the phase 1b trial, we have designed our RENEW trial to test the promise of our dual mechanism approach to targeting alveolar epithelial cell survival and the inhibition of profibrotic signalling in this patient population. We are pleased to have begun screening patients for RENEW.""

The RENEW trial is a phase 2 multi-centre, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and efficacy of LTI-03 in patients with IPF. In addition, the trial is designed to assess the activity of inhaled dry powder LTI-03 across multiple biomarkers and to measure lung function and the potential for healthy tissue regeneration. The trial is designed to 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, including sites in the United States (US), United Kingdom (UK), Germany, Austria and Poland.

Patients will be randomized into two blinded placebo-controlled cohorts that will run concurrently. Patients in the low dose cohort will receive 2.5 mg of either LTI-03 or placebo administered twice daily (BID) for a total dose of 5 mg/day, while participants in the high dose cohort will receive 5 mg BID for a total dose of 10 mg/day. The primary endpoint 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. Patients will undergo a 28-day screening period prior to being randomized and entering the 24-week treatment period, with a four-week follow-up.

Rein previously announced positive topline results from Cohort 2 (5 mg BID) of the phase 1b clinical trial of LTI-03 in IPF, in which a positive trend was observed in seven out of eight biomarkers evaluated, with five biomarkers demonstrating dose-dependent effects and four biomarkers achieving statistical significance in the combined Cohort 1 and Cohort 2 data set.

IPF is a chronic lung disease characterized by progressive tissue scarring that prevents proper lung function. It is a progressive, fatal, age-associated lung disease affecting approximately 100,000 people in the United States. IPF typically presents in adults 65 or older and is usually fatal within two to five years after diagnosis.

LTI-03 is a seven amino acid peptide, the sequence of which is derived from the caveolin scaffolding domain (CSD), an important binding region of the Cav1 protein. Cav1 normally serves a critical function in the prevention of fibrosis by maintaining a balance between pathways that both initiate and arrest lung repair and cell movement. Through the CSD, caveolin interacts with a large number of signalling molecules, all of which possess a caveolin binding domain region. Cav1 expression is decreased in IPF lung tissues and has been demonstrated to decrease during the fibrotic phase of bleomycin, or BLM, lung injury in mice. Restoring the balance of important biological signals in the lung may not only slow lung function decline but could also restore healthy lung function through the protection of healthy epithelial cells."

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