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Celea raises USD 180m to launch first head-to-head superiority trial in IPF

Celea raises USD 180m to launch first head-to-head superiority trial in IPF

Boston-based Celea Therapeutics announced the completion of a USD 180 million private placement to fund initiation of a pivotal Phase III trial in idiopathic pulmonary fibrosis (IPF). The financing positions Celea to pursue the first head-to-head superiority trial in IPF, a design that could establish a new commercial and clinical benchmark if successful.

The round drew a syndicate of named and unnamed investors: RA Capital Management, Leaps by Bayer, and PureTech Health (LSE: PRTC) — Celea's founder and a related-party participant — alongside an undisclosed large US healthcare-focused fund and a leading sovereign wealth fund. No financial intermediaries were named, consistent with a direct private placement structure. PureTech retains a 35.4% equity stake in Celea, up to USD 190 million in regulatory milestones, non-dilutive royalties on net sales, and 20% of sublicense income under the asset transfer agreement executed at Celea's August 2025 launch.

The proceeds will fund the SURPASS-IPF Phase III trial, targeted to initiate in early Q3 2026. SURPASS-IPF is a global, randomized, double-blind, head-to-head study comparing deupirfenidone (LYT-100) 825 mg three times daily against pirfenidone 801 mg three times daily in treatment-naive IPF patients, with change in absolute forced vital capacity at week 52 as the primary endpoint. The trial is designed to demonstrate superiority, not merely non-inferiority, over an approved standard of care — a structurally more demanding and commercially differentiated design than prior IPF pivotal programs. The FDA confirmed at a successful End-of-Phase II meeting in December 2025 that a single Phase III trial, if successful, could support registration via the 505(b)(2) pathway.

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Deupirfenidone is a deuterated analogue of pirfenidone originally licensed from Teva Pharmaceuticals. In the Phase IIb ELEVATE-IPF trial, patients receiving deupirfenidone 825 mg three times daily experienced FVC decline of -21.5 mL at 26 weeks versus -51.6 mL for pirfenidone and -112.5 mL for placebo, with open-label extension data suggesting the effect persists through at least 52 weeks. The compound holds Orphan Drug Designation from both the FDA and European Commission. The IPF antifibrotic market generated combined peak global sales exceeding USD 5 billion for pirfenidone and nintedanib, though treatment uptake has remained persistently constrained by tolerability issues — the precise gap Celea is targeting.


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