PRTC News & Events

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.

PureTech Health announced the completion of the End-of-Phase 2 meeting with the FDA regarding the development of deupirfenidone, or LYT-100, for the treatment of idiopathic pulmonary fibrosis. Deupirfenidone is being advanced by Celea Therapeutics to lead its late-stage development and potential commercialization. The Phase 3 SURPASS-IPF trial will be a global, randomized, double-blind, head-to-head trial comparing deupirfenidone 825 mg three times-a-day to pirfenidone 801 mg in adults with IPF who are not on background therapy. The primary efficacy endpoint is the change from baseline in absolute forced vital capacity at week 52, which will assess the superiority of deupirfenidone compared with pirfenidone. The 52-week trial will use the same active comparator and dosing regimen as the Phase 2b ELEVATE-IPF trial, providing continuity and confidence that the favorable safety profile and strong treatment effect observed previously can be replicated and confirmed in a larger, global population. Based on feedback from the FDA, PureTech believes that the results from this single Phase 3 trial, if successful, and supported by the totality of data from the overall deupirfenidone development program, could complete the data package required to support potential registration of deupirfenidone via a streamlined 505 pathway. PureTech's founded entity, Celea Therapeutics, expects to finalize financing in early 2026 to support the initiation of the Phase 3 SURPASS-IPF trial in the first half of 2026.

PureTech Health announced the presentation of new analyses from the Phase 2b ELEVATE IPF trial of deupirfenidone for the treatment of idiopathic pulmonary fibrosis. The data show that the favorable safety and efficacy profile of deupirfenidone was consistent across age groups, including in patients aged 75 years and older. These findings, presented at the American College of Chest Physicians annual meeting, suggest that deupirfenidone may address a key gap in the treatment of IPF, as older patients have historically been less likely to be treated, largely due to tolerability challenges. These data further reinforce deupirfenidone's differentiated profile and support its potential to meaningfully improve care for this vulnerable population. ELEVATE IPF was a randomized, double-blind, active- and placebo-controlled Phase 2b trial evaluating deupirfenidone 825 mg TID and deupirfenidone 550 mg TID compared to placebo and pirfenidone 801 mg TID in patients with IPF. This sub-analysis primarily focused on safety and tolerability in patients aged 75 years compared with those aged less than 75 years, as tolerability challenges are a primary barrier to treatment in older populations. Treatment emergent adverse events, including gastrointestinal events, were similar for both age groups, indicating that older patients tolerated deupirfenidone comparably to younger patients. For example, the rates of nausea in patients aged 75 years vs. less than75 years were 18.2% vs. 21.4% for deupirfenidone 825 mg TID; 14.3% vs. 18.2% for deupirfenidone 550 mg TID; 25.9% vs. 27.8% for pirfenidone 801 mg TID; and 9.5% vs. 6.8% for placebo. Efficacy also remained consistent with previously reported results, providing additional support for deupirfenidone's differentiated profile in this patient population.