New IPF Data Show Benefit in Older Patients

PureTech Presents New Phase 2b Analyses Demonstrating Consistent Safety and Efficacy of Deupirfenidone in Older Patients with Idiopathic Pulmonary Fibrosis (IPF), a Historically Undertreated Group

Data presented at the CHEST 2025 Annual Meeting highlight deupirfenidone's differentiated profile and potential to address unmet needs across age groups

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, today announced the presentation of new analyses from the Phase 2b ELEVATE IPF trial of deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF). 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 (CHEST) 2025 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.[1],[2] These data further reinforce deupirfenidone's differentiated profile and support its potential to meaningfully improve care for this vulnerable population.

"These data are a welcome indication that age does not necessarily translate to a poorer treatment experience in IPF, which is generally a disease of older people," said Tejaswini Kulkarni, MD, MPH, Associate Professor of Pulmonary, Allergy and Critical Care Medicine at the University of Alabama at Birmingham, who presented the data at CHEST 2025. "Older people with IPF have historically been undertreated and underrepresented in clinical trials because antifibrotic medications can be especially difficult to tolerate for this demographic. Demonstrating consistent safety and efficacy, particularly in this population, reinforces the differentiated profile of deupirfenidone and its potential to benefit a broad range of patients living with IPF."

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 (n=91) compared with those aged <75 years (n=166), 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. <75 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.

"Older patients represent a large and growing segment of the IPF population, yet they've historically been less likely to receive treatment due to concerns around tolerability," said Camilla Graham, MD, MPH, Senior Vice President of Medical Affairs at PureTech. "These findings highlight deupirfenidone's potential to be an attractive treatment option for a broader range of patients, including those who have often been underserved, while maintaining the strong efficacy profile demonstrated in the Phase 2b trial."

About Deupirfenidone (LYT-100)

Deupirfenidone (LYT-100) is in development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). It is a next generation antifibrotic and a deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. The uptake and adherence to approved antifibrotics has historically been limited by a tradeoff between modest efficacy and tolerability, and only ~25% of people with IPF in the U.S. had ever received treatment as of2019.[3]

About Idiopathic Pulmonary Fibrosis (IPF)

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years, and currently there is no cure.[4]

About Celea Therapeutics

Celea was founded by PureTech Health plc (Nasdaq: PRTC, LSE: PRTC), a biotherapeutics company dedicated to giving life to science. PureTech's innovative R&D model drives the creation of Founded Entities like Celea, enabling the advancement of highly promising medicines to patients in a capital-efficient manner. For more information, please visit www.celeatx.com and www.puretechhealth.com.

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[2] Cilli, A., Ocal, N., Uzer, F., Coskun, F., Sevinc, C., Ursavas, A., Yıldız, P., Deniz, P. P., Demirci, N. Y., Ozbey, G., Yurttas, A., & Hanta, I. (2023). Elderly idiopathic pulmonary fibrosis patients remain on therapy despite higher incidence of adverse events and dose reductions. Respiratory Investigation, 61(4), 490-497. https://doi.org/10.1016/j.resinv.2023.04.007