Rein Therapeutics Receives FDA Clearance to Resume U.S. Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis

Core Insights - The FDA has lifted the full clinical hold on Rein Therapeutics' Phase 2 "RENEW" trial for LTI-03, allowing the company to resume patient enrollment [1][2][3] - LTI-03 is a first-in-class inhaled peptide therapy aimed at treating idiopathic pulmonary fibrosis (IPF) by inhibiting lung scarring and promoting lung repair [5][6] - The global market for fibrosis treatments is projected to exceed $11 billion by 2031, highlighting the significant unmet medical need in this area [6] Company Overview - Rein Therapeutics is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies for orphan pulmonary and fibrosis indications [7] - The lead product candidate, LTI-03, has received Orphan Drug Designation in the U.S. and is designed to target alveolar epithelial cell survival while inhibiting profibrotic signaling [7] - The company also has a second product candidate, LTI-01, which has completed Phase 1b and Phase 2a clinical trials for loculated pleural effusions and has received Orphan Drug Designation in both the U.S. and E.U. [7] Trial Details - The RENEW trial will evaluate the safety, tolerability, and efficacy of LTI-03 in up to 120 patients with IPF across approximately 20 U.S. clinical sites and 30 additional sites globally [4] - Key secondary endpoints include changes in lung function (FVC) and imaging-based measures of fibrosis progression, with initial topline data expected in Q3 2026 [4]