BOSTON — PureTech Health plc said results from its Phase 2b ELEVATE IPF trial show that deupirfenidone significantly slowed lung function decline in patients with idiopathic pulmonary fibrosis, with findings published in a leading respiratory medicine journal.
The study found that deupirfenidone 825 mg taken three times daily met both primary and key secondary endpoints, demonstrating a statistically significant and clinically meaningful reduction in lung function decline compared with placebo at 26 weeks.
The adjusted mean difference in forced vital capacity was 91 mL versus placebo, with a p-value of 0.02. Researchers said the rate of decline in lung function in treated patients approached levels typically seen in healthy aging.
Dr. Toby Maher, lead author of the study and a professor of medicine at the Keck School of Medicine at the University of Southern California, said the trial provides important comparative data.
“The ELEVATE IPF trial provides a rare opportunity to evaluate an investigational therapy for IPF directly alongside a current standard-of-care treatment within a randomized controlled trial,” Maher said. “The inclusion of pirfenidone as an active comparator provides important clinical context for interpreting the efficacy and safety findings and increases confidence as this program moves forward into a head-to-head Phase 3 superiority trial. More broadly, the magnitude of the treatment effect demonstrated in this trial suggests that it may be possible to achieve greater preservation of lung function than has historically been observed with currently available therapies. If confirmed at Phase 3, this would have a major impact on our approach to treating patients with IPF.”
The trial also showed a significant delay in disease progression, with a hazard ratio of 0.439 compared with placebo. Pharmacokinetic data indicated that the drug achieved approximately 50 percent greater exposure than pirfenidone, the highest approved dose of a current therapy, without compromising tolerability.
Adverse events were generally mild to moderate and occurred at similar rates between deupirfenidone and pirfenidone. Patient retention rates over 26 weeks were also comparable between treatment and placebo groups.
The randomized, double-blind trial enrolled 257 patients globally and compared multiple doses of deupirfenidone against both placebo and pirfenidone, a standard-of-care treatment. The study used a Bayesian analysis approach to evaluate outcomes while limiting patient exposure to placebo.
Sven Dethlefs, Ph.D., chief executive officer of Celea Therapeutics, said the publication supports further development of the drug.
“Publication in AJRCCM validates the rigor of our Phase 2b trial design and execution and highlights the potential for deupirfenidone to set a new benchmark in the treatment of IPF,” Dethlefs said. “This trial provides a strong scientific and clinical foundation as we prepare to advance deupirfenidone into the Phase 3 SURPASS-IPF trial, with the goal of building on these results to deliver a next-generation antifibrotic that meaningfully improves outcomes for people living with IPF.”
PureTech said its founded entity, Celea Therapeutics, is working to secure financing to begin the Phase 3 SURPASS-IPF trial in the first half of 2026. The upcoming study will compare deupirfenidone directly against pirfenidone in a head-to-head trial designed to test for superiority.
Idiopathic pulmonary fibrosis is a rare and progressive lung disease with no cure, typically leading to death within two to five years of diagnosis.
