Successful FDA Meeting; IPF Phase 3 in 1H26

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

Feedback from U.S. Food and Drug Administration (FDA) supports advancement into a pivotal Phase 3 trial and a 505(b)(2) regulatory pathway

Phase 3 SURPASS-IPF trial remains on track to be initiated by PureTech's Founded Entity, Celea Therapeutics, in the first half of 2026

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.

"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."

The 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 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(b)(2) pathway.

The EOP2 meeting was supported by results from the global Phase 2b randomized, double-blind, active- and placebo-controlled, dose-ranging ELEVATE IPF trial. In that trial, participants treated with deupirfenidone 825 mg TID experienced a slower rate of lung function decline, as measured by change from baseline of Forced Vital Capacity (FVC), at 26 weeks versus those who were treated with pirfenidone 801 mg TID or placebo (-21.5 mL vs. -51.6 mL vs. -112.5 mL, respectively), with a 91 mL difference between deupirfenidone 825 mg and placebo at 26 weeks. Following the completion of the blinded portion of the trial, 170 participants (more than 90%) enrolled in the open-label extension. Those who continued treatment with deupirfenidone 825 mg TID maintained a robust treatment effect and experienced an overall FVC decline of -32.8 mL over a 52-week period,[1] which is similar to the expected natural decline in lung function in healthy older adults over that time (approximately -30.0 mL to -50.0 mL).[2]

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.

About Deupirfenidone (LYT-100)

Deupirfenidone (LYT-100) is in development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). It is a next generation antifibrotic and a deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. The uptake and adherence to approved antifibrotics has historically been limited by a tradeoff between modest efficacy and tolerability, and only ~25% of people with IPF in the U.S. had ever received treatment as of 2019.[3]

About Idiopathic Pulmonary Fibrosis (IPF)

About Celea Therapeutics

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