Rein Therapeutics receives FDA clearance to resume Phase 2 trial of LTI-03

Rein Therapeutics (RNTX) announced that the U.S. Food and Drug Administration has lifted the full clinical hold on the Company’s Phase 2 “RENEW” trial evaluating LTI-03 in patients with idiopathic pulmonary fibrosis. The FDA’s decision follows a review of Rein’s submission, which addressed all of the agency’s concerns. In its correspondence, the FDA confirmed that Study LTI-03-2001 may proceed and that any prior Full Clinical Hold concerns have been fully resolved. Rein expects to resume patient recruitment in late 2025 or early 2026 across approximately 20 U.S. clinical sites located in Alabama, California, Colorado, Connecticut, Florida, Indiana, Kansas, Massachusetts, Michigan, Missouri, North Carolina, New York, Ohio, South Carolina, and Texas. The U.S. enrollment complements Rein’s broader global RENEW study, which includes approximately 30 additional sites in the United Kingdom, Germany, Poland, and Australia. The trial is designed to evaluate the safety, tolerability, and efficacy of LTI-03 in up to 120 patients with IPF. Key secondary endpoints include changes in lung function and imaging-based measures of fibrosis progression. Initial topline data is expected in Q3 2026.