Biotherapeutics company PureTech Health plc (Nasdaq: PRTC) (LSE: PRTC) on Wednesday declared positive Phase 2b results for deupirfenidone (LYT-100) in idiopathic pulmonary fibrosis (IPF), demonstrating statistically significant efficacy and a favorable safety profile. The data were presented at the 2025 American Thoracic Society International Conference.

Patients treated with deupirfenidone 825 mg three times daily showed an 80.9% reduction in lung function decline compared to placebo at 26 weeks, outperforming pirfenidone 801 mg, which achieved a 54.1% reduction. Forced Vital Capacity (FVC) decline in the deupirfenidone group was -21.5 mL versus -112.5 mL for placebo (p=0.02). This rate of decline was in line with that of healthy older adults. Time to IPF progression was significantly delayed with a hazard ratio of 0.439 (p=0.0023).

Preliminary data from an ongoing open-label extension suggest treatment durability over at least 52 weeks, with FVC decline remaining consistent with healthy norms. Among 101 patients completing one year of treatment, average FVC decline was -32.8 mL.

Pharmacokinetic data indicated approximately 50% higher drug exposure with deupirfenidone 825 mg compared to pirfenidone, without increased adverse events. Deupirfenidone was better tolerated, with fewer treatment-emergent adverse events than pirfenidone across the 16 most common categories.

PureTech plans to meet with the U.S. Food and Drug Administration by the end of Q3 2025, aiming to initiate a Phase 3 trial by year-end. The company anticipates providing further regulatory guidance later in 2025.

Deupirfenidone, a deuterated form of pirfenidone, is positioned as a next-generation IPF therapy. Current IPF treatments are limited by tolerability and efficacy; deupirfenidone's profile suggests potential to address these unmet needs and expand into other fibrotic indications.