Biotherapeutics company PureTech Health plc (Nasdaq: PRTC) (LSE: PRTC) has completed a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration for deupirfenidone (LYT-100), supporting advancement into a pivotal Phase 3 trial and a streamlined 505(b)(2) regulatory pathway.

The Phase 3 SURPASS-IPF trial will be initiated in the first half of 2026 by PureTech's Founded Entity, Celea Therapeutics. The global, randomised, double-blind study will compare deupirfenidone 825 mg three times daily with pirfenidone 801 mg three times daily in adults with idiopathic pulmonary fibrosis not receiving background therapy. The primary endpoint will measure change in absolute forced vital capacity at week 52. PureTech believes positive results from this single Phase 3 trial, supported by existing data, could form the basis for potential registration.

FDA discussions were underpinned by results from the Phase 2b ELEVATE-IPF study, which showed a slower decline in lung function with deupirfenidone at 26 weeks versus pirfenidone or placebo, and sustained benefit through 52 weeks in the open-label extension. Celea Therapeutics expects to finalise financing in early 2026 to support trial initiation, and the programme remains aligned with PureTech's cash runway into 2027.

Deupirfenidone is a next-generation antifibrotic designed to offer improved tolerability and efficacy over existing IPF therapies. Beyond IPF, the candidate may also address broader fibrotic lung conditions.

PureTech operates a hub-and-spoke model that develops high-conviction therapeutic assets through Founded Entities such as Celea Therapeutics, three of which have already advanced FDA-approved medicines.