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PRTC: Successful FDA Meeting; IPF Phase 3 in 1H26
PureTech Health plc announced a successful End-of-Phase 2 meeting with the FDA for deupirfenidone (LYT-100) in idiopathic pulmonary fibrosis, supporting advancement into a pivotal Phase 3 trial and a 505(b)(2) regulatory pathway. The Phase 3 SURPASS-IPF trial, comparing deupirfenidone to pirfenidone, is on track to be initiated by Celea Therapeutics in the first half of 2026. Phase 2b ELEVATE IPF trial data showed deupirfenidone 825 mg TID resulted in a slower lung function decline (-21.5 mL FVC change at 26 weeks versus -51.6 mL for pirfenidone and -112.5 mL for placebo), with a 91 mL difference compared to placebo. Disclaimer*
About this update from Puretech Health Plc
[{"type":"text","content":"\n\n8 December 2025\nPureTech Health plc\n \nPureTech Announces Successful End-of-Phase 2 Meeting with FDA for Deupirfenidone (LYT-100) in Idiopathic Pulmonary Fibrosis\n \nFeedback from U.S. Food and Drug Administration (FDA) supports advancement into a pivotal Phase 3 trial and a 505(b)(2) regulatory pathway\n \nPhase 3 SURPASS-IPF trial remains on track to be initiated by PureTech's Founded Entity, Celea Therapeutics, in the first half of 2026\n PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (\"PureTech\" or the \"Company\"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, today announced the successful completion of the End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF). Deupirfenidone is being advanced by Celea Therapeutics, a Founded Entity established by PureTech to lead its late-stage development and potential commercialization.\n \n\"Our discussion with the FDA was productive and provided helpful feedback on key elements of our Phase 3 program and the overall data expectations for registration,\" said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea Therapeutics. \"The forthcoming Phase 3 SURPASS-IPF trial builds on the strong foundation established by the Phase 2b ELEVATE IPF trial, which demonstrated deupirfenidone's robust and durable treatment effect as a monotherapy and its potential to become a new standard of care. In shaping the Phase 3 design, we incorporated learnings from recent IPF trials and collaborated closely with patients and clinicians to reflect the latest thinking in the field. We are now advancing this pivotal program with urgency to bring forward a therapy with the potential to stabilize lung function and meaningfully improve care for people with IPF.\"\n \nThe pivotal Phase 3 SURPASS-IPF trial will be a global, randomized, double-blind, head-to-head trial comparing deupirfenidone 825 mg three times-a-day (TID) to pirfenidone 801 mg TID in adults with IPF who are not on background therapy. The primary efficacy endpoint is the change from baseline in absolute forced vital capacity (FVC) at week 52, which will assess the superiority of deupirfenidone compared wit...