BOSTON — PureTech Health has announced new data from its Phase 2b ELEVATE IPF trial demonstrating that deupirfenidone (LYT-100) significantly slows disease progression in patients with idiopathic pulmonary fibrosis (IPF) while maintaining a favorable safety profile. The results were presented during a late-breaking oral session at the 2025 American Thoracic Society (ATS) International Conference in San Francisco and could position deupirfenidone as a future standard monotherapy for the debilitating lung disease.
In the trial, patients receiving 825 mg of deupirfenidone three times daily (TID) experienced a substantially slower decline in lung function over 26 weeks compared to placebo. The rate of decline in forced vital capacity (FVC)—a key measure of lung function—was just -21.5 mL in the deupirfenidone group, compared to -112.5 mL in those on placebo (p = 0.02). The result represents an 80.9% reduction in lung function decline compared to placebo, surpassing the 54.1% reduction observed in patients treated with pirfenidone 801 mg TID, the current standard therapy.
Further analysis from an open-label extension (OLE) of the study showed that this treatment effect was durable out to 52 weeks. Patients receiving deupirfenidone 825 mg TID experienced an average FVC decline of -32.8 mL over one year, a rate that closely mirrors the natural decline seen in healthy older adults (approximately -30 to -50 mL annually). These findings indicate that deupirfenidone may stabilize lung function over time, an unprecedented result in IPF treatment to date.
“This is one of the most promising studies we’ve seen in IPF in recent years,” said Dr. Toby Maher, Professor of Medicine at the University of Southern California and lead investigator of the ELEVATE IPF trial. “To achieve a lung function decline similar to that of a healthy aging population—without sacrificing tolerability—is remarkable.”
Deupirfenidone’s strong efficacy was supported by a favorable safety profile, with fewer treatment-emergent adverse events (TEAEs) compared to pirfenidone. In the safety analysis, pirfenidone had the highest relative incidence in 9 out of 16 common TEAEs, while deupirfenidone 825 mg led in only 5 categories.
The drug’s pharmacokinetic (PK) profile further reinforced its potential advantages. Despite offering approximately 50% higher drug exposure than pirfenidone, deupirfenidone did not show an increase in tolerability issues—an outcome attributed to its deuterated chemical structure, designed to reduce dose-limiting side effects.
PureTech CEO Dr. Bharatt Chowrira highlighted the importance of these findings, noting that they may redefine what is achievable for patients with IPF. “For the first time, we’re seeing a monotherapy that may slow lung function decline to a rate consistent with healthy aging,” he said. “This level of efficacy and durability has not been observed with current treatments.”
The company is preparing to meet with the U.S. Food and Drug Administration (FDA) by the end of the third quarter of 2025 to discuss a potential Phase 3 registrational trial, which it aims to initiate before year-end.
Dr. Camilla Graham, Senior Vice President of Medical Affairs at PureTech, emphasized the broader implications of the data. “These results suggest that deupirfenidone could offer a highly effective and well-tolerated alternative to current standard-of-care therapies,” she said. “We are optimistic about its potential to improve outcomes for patients living with this progressive and life-limiting disease.”
PureTech plans to provide additional updates later this year as it finalizes its Phase 3 trial design and regulatory strategy.
