PRTC News & Events

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.

PureTech Health notes that its Founded Entity, Seaport Therapeutics, announced topline data from portions of its ongoing Phase 1 proof-of-concept clinical trial evaluating GlyphAgo. GlyphAgo is a novel, Glyphed oral prodrug of agomelatine in development for generalized anxiety disorder and the second clinical-stage candidate from Seaport's pipeline. Based on the data, Seaport announced plans to advance GlyphAgo into two parallel trials, a Phase 2a proof-of-pharmacology trial to evaluate the potential sleep benefit of GlyphAgo in patients with GAD and a Phase 2b randomized placebo-controlled trial in GAD that is designed to be registration-enabling. The GlyphAgo program and the underlying Glyph platform were initially advanced at PureTech, applying the Company's strategy of identifying clinically validated pharmacology and overcoming key limitations through targeted innovation. The Glyph platform and related programs are now being advanced by PureTech's Founded Entity, Seaport Therapeutics.

PureTech Health announced that the U.S. Food and Drug Administration and European Commission have granted Orphan Drug Designation to deupirfenidone for the treatment of idiopathic pulmonary fibrosis, a rare, progressive, and fatal lung disease. Deupirfenidone is being advanced by Celea Therapeutics, a Founded Entity established by PureTech to lead its late-stage development and potential commercialization. Results from the global Phase 2b randomized, double-blind, active- and placebo-controlled, dose-ranging ELEVATE IPF trial underscored the differentiated profile of deupirfenidone. In that trial, participants treated with deupirfenidone 825 mg three times a day experienced a slower rate of lung function decline, as measured by change from baseline of Forced Vital Capacity, at 26 weeks versus those who were treated with the FDA-approved dose of pirfenidone 801 mg TID or placebo, with a 91 mL difference between deupirfenidone 825 mg and placebo at 26 weeks. Following the completion of the blinded portion of the trial, 90% of trial completers enrolled in the open-label extension. Those who continued treatment with deupirfenidone 825 mg TID maintained a robust treatment effect and experienced an overall FVC decline of -32.8 mL over a 52-week period,1 which is similar to the expected natural decline in lung function in healthy older adults over that time.

PureTech Health announces that the board of directors has appointed Robert Lyne as CEO, and as a member of the board of directors, effective immediately. Lyne has served as interim CEO since July and joined PureTech in January 2024 as chief portfolio officer.