Rein Therapeutics Receives European Regulatory Approval to Initiate Phase 2 Trial of LTI-03 in Idiopathic Pulmonary Fibrosis

Core Insights - Rein Therapeutics has received authorization from the European Medicines Agency (EMA) to initiate its Phase 2 "RENEW" clinical trial for LTI-03, targeting idiopathic pulmonary fibrosis (IPF) [1][9] - The trial will take place in Germany and Poland, with prior clearance from the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) [2][3] - The RENEW trial aims to evaluate the safety, tolerability, and efficacy of LTI-03 in up to 120 patients over a 24-week treatment period [4] Company Overview - Rein Therapeutics is a clinical-stage biopharmaceutical company focused on developing first-in-class therapies for orphan pulmonary and fibrosis indications [8] - LTI-03 is a synthetic peptide designed to inhibit fibrosis and support lung tissue regeneration by protecting alveolar progenitor cells [5][8] - The company also has a second product candidate, LTI-01, which has completed Phase 1b and Phase 2a trials for loculated pleural effusions and has received Orphan Drug Designation in both the U.S. and E.U. [8] Disease Context - Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease characterized by irreversible scarring, leading to severe breathing difficulties, with a median survival of 3-5 years post-diagnosis [6] - The estimated prevalence of IPF is 13 to 20 per 100,000 people globally, with around 100,000 cases in the U.S. and 30,000 to 40,000 new diagnoses each year [7]