BOSTON, July 13, 2026
Celea Therapeutics announced that the first patient has been dosed in the global Phase 3 SURPASS-IPF trial evaluating deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF). The potentially registrational, randomized, double-blind study will compare deupirfenidone 825 mg three times daily with pirfenidone 801 mg three times daily in adults with IPF who are not receiving background antifibrotic therapy. Following the company’s recent $180 million financing, the trial marks a major milestone in advancing deupirfenidone as a potential new standard of care. Topline results are expected in the second half of 2029.
Global Head-to-Head Trial Targets Superior Efficacy
SURPASS-IPF is the first industry-sponsored head-to-head Phase 3 trial in idiopathic pulmonary fibrosis designed to evaluate whether deupirfenidone is superior to the current approved antifibrotic therapy, pirfenidone. The study is expected to enroll approximately 1,100 patients across more than 30 countries, with change from baseline in absolute forced vital capacity (FVC) at Week 52 serving as the primary endpoint. The trial will also further evaluate the overall safety and tolerability profile of deupirfenidone while ensuring that every participant receives active treatment through the absence of a placebo arm.
Phase 2b Results Support Registrational Development
The Phase 3 program builds on encouraging findings from the Phase 2b ELEVATE-IPF trial and its open-label extension, where deupirfenidone demonstrated the potential to substantially slow lung function decline while maintaining a favorable safety and tolerability profile for at least 52 weeks. Celea designed SURPASS-IPF using the same dosing regimen and active comparator evaluated in Phase 2b, providing continuity across the clinical development program while expanding assessment to a much larger global patient population.
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Potential New Standard of Care for Idiopathic Pulmonary Fibrosis
Deupirfenidone is an investigational, next-generation antifibrotic therapy and a deuterated form of pirfenidone that has received Orphan Drug Designation from both the U.S. FDA and the European Commission. Based on FDA feedback, results from the Phase 3 SURPASS-IPF trial, together with the existing clinical data package, may provide sufficient evidence to support a future U.S. regulatory submission. With first patient dosing now underway, Celea aims to establish deupirfenidone as a more effective and well-tolerated treatment option for patients living with idiopathic pulmonary fibrosis, a progressive and fatal lung disease with limited therapeutic options.
Source: Celea Therapeutics press release
