PureTech Health Announces ELEVATE IPF Trial Results

PureTech Health announced the publication of results from the Phase 2b ELEVATE IPF trial of deupirfenidone for the potential treatment of idiopathic pulmonary fibrosis in The American Journal of Respiratory and Critical Care Medicine. The results from this trial informed the design of the upcoming Phase 3 SURPASS-IPF trial, which will evaluate deupirfenidone 825 mg three times a day monotherapy as compared to pirfenidone 801 mg TID monotherapy, in a head-to-head study powered to test for superiority. PureTech's Founded Entity, Celea Therapeutics, is working to complete a financing to enable the initiation of the Phase 3 SURPASS-IPF trial in the first half of 2026. Highlights from the publication have been presented in various scientific forums throughout the course of 2025 and include: Primary and key secondary endpoints achieved: Deupirfenidone demonstrated a 98.5% and 99.6% posterior probability of superiority vs. placebo in slowing forced vital capacity and forced vital capacity percent predicted decline, respectively, at 26 weeks based on the prespecified Bayesian analysis. Statistically significant and clinically meaningful preservation of lung function: Deupirfenidone 825 mg TID as a monotherapy significantly slowed lung function decline versus placebo at 26 weeks as measured by mean FVC. A secondary analysis of FVCpp also showed a statistically significant benefit. Lung function decline approached the range expected with healthy aging: In the deupirfenidone 825 mg TID arm, the rate of FVC decline over 26 weeks approached the normal physiological decline expected in healthy older adults. Although not included in the publication, data from the ongoing Phase 2b ELEVATE IPF open-label extension show that this treatment effect was maintained out to at least 52 weeks, with participants experiencing a decline in FVC of -32.8 mL3. This is also similar to the expected natural decline in lung function in healthy older adults over that time. Delay in disease progression: Time to IPF progression, defined as an absolute decline in FVCpp of greater than or equal to5% or death through 26 weeks, was significantly delayed in patients receiving deupirfenidone 825 mg TID compared with placebo. Greater drug exposure without sacrificing tolerability: Pharmacokinetic data show that deupirfenidone 825 mg TID results in an approximately 50% greater drug exposure compared to pirfenidone 801 mg TID. Importantly, the overall incidence of adverse events with deupirfenidone 825 mg TID was similar to that of pirfenidone 801 mg TID, and AEs were generally mild to moderate. The percentage of patients who remained on deupirfenidone 825 mg TID for 26 weeks was similar to the percentage of patients remaining on placebo. Taken together, these data suggest that the higher exposure and improved efficacy observed with deupirfenidone 825 mg TID were achieved without sacrificing tolerability.