Rein Therapeutics (NASDAQ: RNTX) announced that the U.S. Food and Drug Administration has lifted the full clinical hold on its Phase 2 RENEW trial of LTI-03 in idiopathic pulmonary fibrosis (IPF) after reviewing Rein’s complete response submission.
The company expects to resume U.S. enrollment in late 2025 or early 2026 across ~20 U.S. sites, complementing ~30 global sites. The study will enroll up to 120 patients, assess safety, tolerability and efficacy with key secondaries including FVC and imaging measures, and plans initial topline data in Q3 2026. Rein stated early data suggest LTI-03 may slow fibrosis and support lung repair.
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