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
“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
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
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
Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from an ongoing open-label extension study suggest this effect may be sustained through at least 52 weeks. These findings support the potential for deupirfenidone to offer a meaningful advance for people living with this progressive and deadly disease. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases.
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 Therapeutics is dedicated to advancing transformative treatments for people with serious respiratory diseases. Drawn from the Latin word for “sky,” the name reflects the company’s mission to rise above the status quo and deliver therapies that change lives. The company’s lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate with the potential to set a new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.
Celea was founded by
About
For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements that relate to continued development of and regulatory interactions related to deupirfenidone, the potential of deupirfenidone in IPF and other indications, our expectations around our therapeutic candidates and approach towards addressing major diseases, our plans to advance our programs and deliver on our milestones, our future plans, prospects, developments, and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended
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1 Qiu, Y., Zhu, J., Chopra, P., Elpers, B., Dieyi, C., Byrne, C., Tang, J., Wang, Y., Govindaraj, K., & Fischer, A. (2024). Real-world antifibrotic treatment patterns in patients with idiopathic pulmonary fibrosis: retrospective analyses of two large healthcare administrative databases in |
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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 |
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3 Dempsey, T. M., Payne, S., Sangaralingham, L., Yao, X., Shah, N. D., & Limper, A. H. (2021). Adoption of the antifibrotic medications pirfenidone and nintedanib for patients with idiopathic pulmonary fibrosis. Annals of the |
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4 Fisher, M., Nathan, S. D., Hill, C., Marshall, J., |
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