PureTech Announces Successful End-of-Phase 2 Meeting with FDA for Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis

Core Insights - PureTech Health plc announced the successful completion of the End-of-Phase 2 meeting with the FDA regarding deupirfenidone (LYT-100) for idiopathic pulmonary fibrosis (IPF) treatment [1][2] - The Phase 3 SURPASS-IPF trial will compare deupirfenidone 825 mg three times a day to pirfenidone 801 mg three times a day, with a primary efficacy endpoint of change in absolute forced vital capacity (FVC) at week 52 [2][3] - Deupirfenidone has shown a slower rate of lung function decline in the Phase 2b ELEVATE IPF trial, with a 91 mL difference in FVC decline compared to placebo at 26 weeks [3][6] Company Overview - PureTech Health is a biotherapeutics company focused on transforming innovation into value through a capital-efficient R&D model [11] - Celea Therapeutics, a subsidiary of PureTech, is dedicated to advancing treatments for serious respiratory diseases, with deupirfenidone as its lead program [9][10] Clinical Development - The Phase 3 SURPASS-IPF trial is set to begin in the first half of 2026, with financing expected to be finalized by early 2026 [4] - The ELEVATE IPF trial demonstrated that deupirfenidone maintained a favorable safety profile while stabilizing lung function decline over at least 26 weeks [6] Market Context - Deupirfenidone is positioned as a next-generation antifibrotic and a potential new standard of care for IPF, addressing limitations of existing therapies [5][6] - Historically, only about 25% of IPF patients in the U.S. have received treatment, indicating a significant unmet need in the market [5]