PureTech Health Completes FDA Phase 2 Meeting, Advances LYT-100 Development

PureTech Health announced the completion of the End-of-Phase 2 meeting with the FDA regarding the development of deupirfenidone, or LYT-100, for the treatment of idiopathic pulmonary fibrosis. Deupirfenidone is being advanced by Celea Therapeutics to lead its late-stage development and potential commercialization. The Phase 3 SURPASS-IPF trial will be a global, randomized, double-blind, head-to-head trial comparing deupirfenidone 825 mg three times-a-day to pirfenidone 801 mg in adults with IPF who are not on background therapy. The primary efficacy endpoint is the change from baseline in absolute forced vital capacity at week 52, which will assess the superiority of deupirfenidone compared with pirfenidone. The 52-week trial will use the same active comparator and dosing regimen as the Phase 2b ELEVATE-IPF trial, providing continuity and confidence that the favorable safety profile and strong treatment effect observed previously can be replicated and confirmed in a larger, global population. Based on feedback from the FDA, PureTech believes that the results from this single Phase 3 trial, if successful, and supported by the totality of data from the overall deupirfenidone development program, could complete the data package required to support potential registration of deupirfenidone via a streamlined 505 pathway. PureTech's founded entity, Celea Therapeutics, expects to finalize financing in early 2026 to support the initiation of the Phase 3 SURPASS-IPF trial in the first half of 2026.