SURPASS-IPF is the first industry-sponsored Phase 3 head-to-head trial comparing an investigational drug to an approved antifibrotic in patients with idiopathic pulmonary fibrosis (IPF)
Considerations of statistical methods illustrate how analytical choices affect perceptions of efficacy, highlighting differences in parametric and non-parametric approaches
BOSTON--(BUSINESS WIRE)--Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company focused on developing differentiated therapies for serious respiratory diseases with significant unmet medical need, today announced that the Company will deliver two poster presentations showcasing its deupirfenidone (LYT-100) program at the IPF Summit, taking place in Boston, MA, from September 29 to October 1, 2026. Deupirfenidone is an investigational therapy in Phase 3 development with the potential to serve as a new standard of care for the treatment of IPF.
The first poster will detail the design and rationale for SURPASS-IPF, Celea’s global Phase 3 trial evaluating the potential superiority of deupirfenidone 825 mg three times daily (TID) versus pirfenidone 801 mg TID. SURPASS-IPF is the first industry-sponsored Phase 3 head-to-head trial comparing an investigational drug to an approved antifibrotic in patients with IPF. The second poster will examine statistical considerations for evaluating forced vital capacity (FVC), a widely used measure of disease progression and primary endpoint in many IPF clinical trials, including SURPASS-IPF, with a focus on how analytical choices may affect perceptions of efficacy.
“Building on positive Phase 2b results, SURPASS-IPF takes an important next step by directly comparing deupirfenidone to pirfenidone in IPF,” said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. “We are applying carefully considered statistical methods to rigorously evaluate whether deupirfenidone is superior to a current standard of care, with the goal of generating clear, robust evidence that can help advance treatment for people living with IPF.”
Details of the presentations are as follows:
Title: SURPASS-IPF: Study Design of a Phase 3, Head-to-Head Trial of Deupirfenidone Versus Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis
Presenter: Toby Maher, M.D., Ph.D., Director of Interstitial Lung Disease, Keck School of Medicine of the University of Southern California
Session: Afternoon Break & Poster Session
Date and Time: September 30, 2026, 4:00 PM EDT
Title: Statistical Consideration of the Phase 3 Deupirfenidone vs Pirfenidone Trial: SURPASS-IPF
Presenter: Toby Maher, M.D., Ph.D., Director of Interstitial Lung Disease, Keck School of Medicine of the University of Southern California
Session: Afternoon Break & Poster Session
Date and Time: September 30, 2026, 4:00 PM EDT
About SURPASS-IPF
SURPASS-IPF (NCT07284602) is a global, randomized, double-blind, head-to-head Phase 3 trial evaluating the superiority of deupirfenidone 825 mg TID over pirfenidone 801 mg TID in approximately 1,100 adults living with IPF who are not receiving background antifibrotic therapy. The primary endpoint is change from baseline in absolute FVC at Week 52. For more information, please visit www.SURPASS-IPF.com.
About Deupirfenidone (LYT-100)
Deupirfenidone (LYT-100) is in Phase 3 development as a potential new standard of care for the treatment of IPF and has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and European Commission. It is an investigational, next-generation antifibrotic and a deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. The uptake of 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 of 2019.[1]
Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, published in The American Journal of Respiratory and Critical Care Medicine (AJRCCM), 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 the open-label extension trial 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)
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,[2] and currently there is no cure.
About Celea Therapeutics
Celea Therapeutics is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for serious respiratory diseases with significant unmet medical need. Celea’s therapeutic candidate, deupirfenidone, is an investigational next-generation oral antifibrotic therapy being evaluated in a Phase 3 clinical program for IPF, a progressive and fatal lung disease. Building on the established antifibrotic foundation of pirfenidone, deupirfenidone is being developed with the goal of improving outcomes for people living with IPF and potentially other progressive fibrotic interstitial lung diseases.
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[1] 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 American Thoracic Society, 18(7), 1121-1128. |
[2] Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting life expectancy for pirfenidone in idiopathic pulmonary fibrosis. Journal of Managed Care & Specialty Pharmacy, 23(3-b Suppl), S17-S24. |
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Celea
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info@celeatx.com
US Media
Justin Chen
TBCCelea@tenbridgecommunications.com
