Boston-based PureTech has released new data from a Phase IIb ELEVATE IPF trial for deupirfenidone (LYT-100), showing it significantly slowed lung function decline while maintaining a favorable safety profile in patients with idiopathic pulmonary fibrosis (IPF).
The results were presented at the American Thoracic Society (ATS) 2025 International Conference, taking place from 16 to 21 May in San Francisco (US). The data indicated that deupirfenidone 825 mg taken three times daily (TID) not only demonstrated a statistically significant reduction in disease progression compared to placebo over 26 weeks but also showed sustained benefits in an open-label extension study over 52 weeks.
Following the news, PureTech’s stock was up by over 9.7% in market trading today (21 May). The company’s market cap currently stands at $450 million.
According to PureTech, these results suggest that deupirfenidone may bring lung function decline in IPF patients close to the rate expected in healthy older adults—an unprecedented outcome for a monotherapy in this disease area.
Dr. Toby Maher, lead investigator of the ELEVATE IPF trial and Professor of Medicine at the Keck School of Medicine, USC, remarked, “The ability for a monotherapy to reduce lung function decline close to a level seen in healthy older adults, and to sustain that effect over time without compromising tolerability, is not something we have seen with currently available therapies.”
Trial results
The randomized, double-blind trial evaluated 257 participants receiving either deupirfenidone at two dosing levels, pirfenidone (an existing standard-of-care treatment), or placebo. At 26 weeks, patients on deupirfenidone 825 mg TID experienced a decline in Forced Vital Capacity (FVC)—a key measure of lung function—of just -21.5 mL, compared to -112.5 mL for placebo. This represents a robust 80.9% reduction in decline versus placebo, significantly outperforming pirfenidone, which showed a 54.1% reduction.
These effects were mirrored in the trial’s open-label extension, where patients continued treatment beyond 26 weeks. Those receiving deupirfenidone 825 mg TID showed a 52-week decline of only -32.8 mL, a rate consistent with lung function loss due to normal aging. “These data are quite remarkable,” said PureTech CEO Bharatt Chowrira. “To our knowledge, this level of efficacy has not been observed with other monotherapies.”
The safety profile of deupirfenidone was also notably favorable. In analyses of the most common treatment-emergent adverse events (TEAEs), the highest incidence was seen in the pirfenidone group for nine of the 16 most frequent TEAEs. Deupirfenidone 825 mg was associated with only five, placebo with two, and the lower 550 mg deupirfenidone dose with none—highlighting the tolerability advantage of the new compound.
PureTech attributes part of this benefit to deupirfenidone’s chemical design. As a deuterated version of pirfenidone, it achieves higher drug exposure—approximately 50% greater—without triggering a corresponding rise in adverse effects, suggesting that its unique structure may overcome the limitations of current treatments.
PureTech plans to meet with the US Food and Drug Administration (FDA) by the end of the third quarter of 2025 to align on a Phase III registrational trial, which it hopes to launch by year’s end.
