A Randomized, Double-Blind, Head-to-Head Phase 3 Trial to Evaluate the Efficacy and Safety of LYT-100 (Deupirfenidone) Compared to Pirfenidone at 52 Weeks in Adults With Idiopathic Pulmonary Fibrosis (SURPASS-IPF)

This is a study for adults with a lung disease called idiopathic pulmonary fibrosis. The main purpose of this study is to look at how well deupirfenidone improves lung function and how safe it is for people with idiopathic pulmonary fibrosis (IPF) when compared with pirfenidone. Participants may have been treated with an approved antifibrotic drug for up to a year in the past, but they cannot be on background antifibrotic treatment during this study. Participants will be randomly assigned (meaning by chance) to take either deupirfenidone or pirfenidone 3 times a day, and neither a participant nor their study team will know which study drug participants are on. Participants will be in the study for up to approximately 3 years. During the first year, participants visit the study site up to ten times and afterwards they visit the site every three months. All participants will remain on blinded study drug until the last participant has completed Week 52 Visit. They will have lung function tests, a check of their health, and will tell the study team about any unfavorable effects.

开始日期2026-06-26

申办/合作机构

PureTech Health Plc

CTRI/2023/02/050138

/ Recruiting临床2期

A Randomized, Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients with Idiopathic Pulmonary Fibrosis (IPF).

开始日期2023-03-30

申办/合作机构

Puretech LYT, Inc.

NCT05321420

/ Active, not recruiting临床2期

A Randomized Double-blind, Four-Arm Active and Placebo-controlled Dose-Finding Trial to Evaluate the Efficacy, Tolerability, Safety and Dose Response of LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.

开始日期2022-07-22

申办/合作机构

PureTech Health Plc

100 项与 Deupirfenidone 相关的临床结果

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100 项与 Deupirfenidone 相关的转化医学

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100 项与 Deupirfenidone 相关的专利（医药）

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项与 Deupirfenidone 相关的文献（医药）

2026-08-01·AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE

Deupirfenidone compared with pirfenidone and placebo in idiopathic pulmonary fibrosis (ELEVATE-IPF): a phase 2b randomized placebo-controlled trial

Article

Abstract:

Rationale:

Deupirfenidone is a strategically deuterated form of pirfenidone that retains pharmacodynamic activity but has a differentiated pharmacokinetic profile that may enable improved efficacy and favorable tolerability in patients with idiopathic pulmonary fibrosis (IPF).

Objectives:

To evaluate the efficacy and safety of deupirfenidone compared with placebo and pirfenidone in patients with IPF.

Methods:

Patients were randomized 1:1:1:1 to deupirfenidone 550 mg TID, deupirfenidone 825 mg TID, pirfenidone 801 mg TID, or placebo. The primary endpoint was the rate of change in forced vital capacity (FVC) for the combined arms of deupirfenidone versus placebo at 26 weeks. The primary and secondary analyses used Bayesian and frequentist approaches, respectively.

Measurements and Main Results:

A total of 257 patients with IPF were randomized, and the proportion on treatment at the end of the study was 80.0%, 68.3%, 64.6%, and 78.1% for the placebo, pirfenidone, deupirfenidone 550 mg, and deupirfenidone 825 mg arms, respectively. Posterior mean change in FVC for placebo was -110.71 mL (95% credible interval (CI), -148.75, -70.98), and for the combined deupirfenidone arms was -48.42 mL (95% CI, -87.66, -9.04) with a posterior mean difference of 62.29 mL (95% CI l, -6.13, 115.73; posterior probability, 0.985). Using a frequentist approach, the adjusted mean change in FVC for the placebo arm was -112.5 mL (95% CI, -167.2, -57.8), and for the deupirfenidone 825 mg arm was -21.5 mL (95% CI, -78.2, 35.1); the adjusted mean difference was 91.0 mL (95% CI, 12.2, 169.7; P = .02). The most common adverse events for each active treatment arm were gastrointestinal.

Conclusions:

In patients with IPF, treatment with deupirfenidone slowed lung disease progression over 26 weeks.

Trial Registration:

Clinicaltrials.gov number NCT05321420.

2025-07-01·ERJ Open Research

Deupirfenidone (LYT-100) in post-acute sequelae of SARS-CoV-2 with respiratory complications

Article

作者: Harnett, Mark ; Santiaguel, Joel ; Krop, Julie ; Kulkarni, Tejaswini ; Aul, Raminder ; Chen, Michael C ; Maher, Toby M ; Graham, Camilla S

Introduction:

The pathophysiology of respiratory complications in post-acute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (PASC) is poorly understood, but a high incidence of progressive pulmonary fibrosis was anticipated. Deupirfenidone (LYT-100) is a selectively deuterated form of pirfenidone that retains antifibrotic and anti-inflammatory activity but with improved tolerability. This study evaluated the safety and efficacy of deupirfenidone in PASC patients with respiratory complications.

Methods:

Global, double-blind, randomised placebo-controlled trial evaluating 750 mg deupirfenidone twice daily versus placebo for 3 months in PASC patients with respiratory complications following hospitalisation for acute COVID-19 infection severe enough to necessitate supplemental oxygen (NCT04652518).

Results:

185 patients were randomised and treated (95 with deupirfenidone, 90 with placebo), with 177 included in the modified intention-to-treat population. The mean age was 54.5 years, 62.7% were male and 10.7% had prior mechanical ventilation. The 6-min walk distance improved across both arms between baseline and day 91 (deupirfenidone 44.3 m (95% CI 24.8–63.8 m) versus placebo 48.8 m (95% CI 29.2–68.4 m); p=0.70). The most common treatment-emergent adverse events (TEAEs) for deupirfenidone versus placebo were nausea (9.5% versus 1.1%), upper abdominal discomfort (5.3% versus 2.2%) and dyspepsia (6.3% versus 1.1%). TEAEs leading to trial drug discontinuation were 11.6% for deupirfenidone and 4.4% for placebo. The proportion of discontinuations considered at least possibly related to treatment was 8.6% for deupirfenidone and 2.4% for placebo.

Discussion:

Most patients with PASC and respiratory complications showed significant improvement over 91 days irrespective of treatment assignment. Deupirfenidone was well tolerated, with low rates of TEAEs, which supports further investigation in patients with idiopathic pulmonary fibrosis.

2022-02-01·Clinical pharmacology in drug development

A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel Deuterium‐Containing Drug Candidate for Interstitial Lung Disease and Other Inflammatory and Fibrotic Diseases

Article

作者: Elenko, Eric ; Lickliter, Jason D. ; Harnett, Mark D. ; Korth, Christopher C. ; Chen, Michael C.

Abstract:

LYT‐100 (deupirfenidone) is a selectively deuterated form of pirfenidone under development for the treatment of inflammatory and fibrotic diseases, including interstitial lung disease. Adverse events associated with antifibrotics can be a barrier to adoption and persistence in patients with interstitial lung diseases, most of whom are not on standard‐of‐care therapy. LYT‐100 is designed to have a differentiated pharmacokinetic (PK) profile from pirfenidone and could offer a differentiated safety profile compared to current standard‐of‐care drugs while retaining the biochemical potency and specificity of pirfenidone. We conducted a phase 1b study to ascertain the safety, tolerability, steady‐state PK profile, and food effect of LYT‐100. This was a 2‐part study. Part 1 assessed multiple ascending doses of LYT‐100 from 100, 250, 500, 750, and 1000 mg twice daily given over 5 days without titration. Part 2 assessed the effects of fed vs fasting conditions on the PK profile of a single 500‐mg dose of LYT‐100. All doses up to 1000 mg were well tolerated, with adverse events being mild and transient. Exposure was slightly lower in the fed condition. LYT‐100 was well tolerated and has a dose‐proportional PK profile. The ratio of parent to major metabolite concentration was higher than reported with pirfenidone, which is consistent with an effect of deuteration on metabolism. No maximum tolerated dose was identified up to 1000 mg twice‐daily dosing. These results support further clinical development of LYT‐100, particularly considering the adverse event profile of current standard‐of‐care drugs.

项与 Deupirfenidone 相关的新闻（医药）

2026-08-25

·news.puretechhealth.com

PureTech Founded Entity Celea Therapeutics to Deliver Two Presentations at the Upcoming European Respiratory Society (ERS) Congress

25 August 2026 PureTech Health plc PureTech Founded Entity Celea Therapeutics to Deliver Two Presentations at the Upcoming European Respiratory Society (ERS) Congress Presentations will highlight Celea's differentiated approach to advancing deupirfenidone for idiopathic pulmonary fibrosis (IPF), including details of the Phase 3 SURPASS-IPF trial design and key insights from a Phase 1 drug-drug interaction study with nintedanib PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, is pleased to note that its Founded Entity Celea Therapeutics ("Celea") today announced that it will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 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 idiopathic pulmonary fibrosis (IPF). The full text of the announcement from Celea is as follows: Celea Therapeutics Will Present Phase 3 Trial Design for Idiopathic Pulmonary Fibrosis and Key Insights from a Deupirfenidone Drug-Drug Interaction Study at the Upcoming European Respiratory Society (ERS) Congress SURPASS-IPF is the first industry-sponsored Phase 3 head-to-head trial in idiopathic pulmonary fibrosis (IPF) and will evaluate the potential superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Phase 1 drug-drug interaction study demonstrates that clinically relevant drug-drug interactions with deupirfenidone and nintedanib co-administration are unlikely BOSTON, August 25, 2026 - Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company dedicated to advancing transformative treatments for people with serious respiratory diseases, today announced that the Company will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 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 idiopathic pulmonary fibrosis (IPF). The presentations 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 will assess not only several clinical endpoints but also the potential impact on patients' lives via patient-reported outcomes. For the first time, Celea will also share results from a Phase 1 drug-drug interaction study evaluating co-administration of deupirfenidone and nintedanib. "Developed in close collaboration with the patient community, clinicians, and payers, SURPASS-IPF is rigorously evaluating deupirfenidone's potential to establish a new benchmark for the treatment of IPF. Importantly, the trial goes beyond standard endpoints such as forced vital capacity (FVC) to assess additional patient-reported outcomes that reflect meaningful improvements in patients' quality of life," said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. "As the first industry-sponsored head-to-head Phase 3 trial in IPF, SURPASS-IPF demonstrates our confidence in deupirfenidone, the body of clinical evidence supporting it, and its ability to potentially transform the treatment paradigm with a level of anticipated efficacy previously thought achievable only through combination approaches." Details of the presentations are as follows: Title: Design of SURPASS-IPF: A Personalized Approach to a Phase 3 Trial of Deupirfenidone Compared to Pirfenidone in Idiopathic Pulmonary Fibrosis Presenter: Vincent Cottin, M.D., Louis Pradel Hospital, Claude Bernard University Lyon 1 Session: 70 - Poster session: Novel therapies and biomarkers in idiopathic pulmonary fibrosis (located in PS-34) Date and Time: September 6, 2026, 8:00-9:30 AM CEST Title: A Phase 1 Two-way Drug Interaction Study of Deupirfenidone (LYT-100) and Nintedanib Presenter: Philip Molyneaux, Ph.D., Professor of Interstitial Lung Disease, Imperial College London Session: 325 - Oral presentation: Moving forward in interstitial lung disease: new data on novel therapies (located in 3K) Date and Time: September 7, 2026, 11:05 AM CEST For additional information, those attending the ERS Congress can visit Celea at Booth H.02. 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 three times daily (TID) over pirfenidone 801 mg TID in approximately 1,100 adults living with idiopathic pulmonary fibrosis (IPF) who are not receiving background antifibrotic therapy. The primary endpoint is change from baseline in absolute forced vital capacity (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 idiopathic pulmonary fibrosis (IPF) and has been granted Orphan Drug Designation from the U.S. Food and Drug Administration 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 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,2 and currently there is no cure. 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. Celea's lead program, deupirfenidone (LYT-100), is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by PureTech Health plc (LSE: PRTC), a hub-and-spoke biotherapeutics company dedicated to giving life to science. For more information, please visit www.celeatx.com. About PureTech Health PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value. We do this through a proven, capital-efficient R&D model focused on opportunities with validated pharmacology and untapped potential to address significant patient needs. This strategy has produced dozens of therapeutic candidates, including three that have received U.S. FDA approval. By identifying, shaping, and de-risking these high-conviction assets, and scaling them through dedicated structures backed by external capital, we accelerate their path to patients while creating sustainable value for shareholders. For more information, visit www.puretechhealth.com or connect with us on LinkedIn and 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 those related to the planned development of deupirfenidone and our and Celea's future 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 December 31, 2025, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Contact: PureTech Public Relations publicrelations@puretechhealth.com Investor Relations IR@puretechhealth.com UK/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 puretech@fticonsulting.com U.S. Media Justin Chen jchen@tenbridgecommunications.com [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. END NRAEAFPSAEKKEEA

临床3期临床结果临床1期临床2期孤儿药

2026-08-25

·BioSpace

PureTech Founded Entity Celea Therapeutics to Deliver Two Presentations at the Upcoming European Respiratory Society (ERS) Congress

Presentations will highlight Celea’s differentiated approach to advancing deupirfenidone for idiopathic pulmonary fibrosis (IPF), including details of the Phase 3 SURPASS-IPF trial design and key insights from a Phase 1 drug-drug interaction study with nintedanib BOSTON--(BUSINESS WIRE)-- PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, is pleased to note that its Founded Entity Celea Therapeutics (“Celea”) today announced that it will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 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 idiopathic pulmonary fibrosis (IPF). The full text of the announcement from Celea is as follows: Celea Therapeutics Will Present Phase 3 Trial Design for Idiopathic Pulmonary Fibrosis and Key Insights from a Deupirfenidone Drug-Drug Interaction Study at the Upcoming European Respiratory Society (ERS) Congress SURPASS-IPF is the first industry-sponsored Phase 3 head-to-head trial in idiopathic pulmonary fibrosis (IPF) and will evaluate the potential superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Phase 1 drug-drug interaction study demonstrates that clinically relevant drug-drug interactions with deupirfenidone and nintedanib co-administration are unlikely BOSTON, August 25, 2026 – Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company dedicated to advancing transformative treatments for people with serious respiratory diseases, today announced that the Company will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 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 idiopathic pulmonary fibrosis (IPF). The presentations 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 will assess not only several clinical endpoints but also the potential impact on patients’ lives via patient-reported outcomes. For the first time, Celea will also share results from a Phase 1 drug-drug interaction study evaluating co-administration of deupirfenidone and nintedanib. “Developed in close collaboration with the patient community, clinicians, and payers, SURPASS-IPF is rigorously evaluating deupirfenidone’s potential to establish a new benchmark for the treatment of IPF. Importantly, the trial goes beyond standard endpoints such as forced vital capacity (FVC) to assess additional patient-reported outcomes that reflect meaningful improvements in patients’ quality of life,” said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. “As the first industry-sponsored head-to-head Phase 3 trial in IPF, SURPASS-IPF demonstrates our confidence in deupirfenidone, the body of clinical evidence supporting it, and its ability to potentially transform the treatment paradigm with a level of anticipated efficacy previously thought achievable only through combination approaches.” Details of the presentations are as follows: Title: Design of SURPASS-IPF: A Personalized Approach to a Phase 3 Trial of Deupirfenidone Compared to Pirfenidone in Idiopathic Pulmonary Fibrosis Presenter: Vincent Cottin, M.D., Louis Pradel Hospital, Claude Bernard University Lyon 1 Session: 70 – Poster session: Novel therapies and biomarkers in idiopathic pulmonary fibrosis (located in PS-34) Date and Time: September 6, 2026, 8:00-9:30 AM CEST Title: A Phase 1 Two-way Drug Interaction Study of Deupirfenidone (LYT-100) and Nintedanib Presenter: Philip Molyneaux, Ph.D., Professor of Interstitial Lung Disease, Imperial College London Session: 325 – Oral presentation: Moving forward in interstitial lung disease: new data on novel therapies (located in 3K) Date and Time: September 7, 2026, 11:05 AM CEST For additional information, those attending the ERS Congress can visit Celea at Booth H.02. 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 three times daily (TID) over pirfenidone 801 mg TID in approximately 1,100 adults living with idiopathic pulmonary fibrosis (IPF) who are not receiving background antifibrotic therapy. The primary endpoint is change from baseline in absolute forced vital capacity (FVC) at Week 52. For more information, please visit . About Deupirfenidone (LYT-100) Deupirfenidone (LYT-100) is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and has been granted Orphan Drug Designation from the U.S. Food and Drug Administration 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 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, 2 and currently there is no cure. 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. Celea’s lead program, deupirfenidone (LYT-100), is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by PureTech Health plc (LSE: PRTC), a hub-and-spoke biotherapeutics company dedicated to giving life to science. For more information, please visit . About PureTech Health PureTech Health is a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value. We do this through a proven, capital-efficient R&D model focused on opportunities with validated pharmacology and untapped potential to address significant patient needs. This strategy has produced dozens of therapeutic candidates, including three that have received U.S. FDA approval. By identifying, shaping, and de-risking these high-conviction assets, and scaling them through dedicated structures backed by external capital, we accelerate their path to patients while creating sustainable value for shareholders. For more information, visit or connect with us on LinkedIn and 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 those related to the planned development of deupirfenidone and our and Celea’s future 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 December 31, 2025, filed with the SEC and in our other regulatory filings. These forward-looking statements are based on assumptions regarding the present and future business strategies of the Company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, we disclaim any obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. [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. Contacts PureTech Public Relations publicrelations@puretechhealth.com Investor Relations IR@puretechhealth.com UK/EU Media Ben Atwell, Rob Winder +44 (0) 20 3727 1000 puretech@fticonsulting.com U.S. Media Justin Chen jchen@tenbridgecommunications.com

临床3期临床结果临床2期临床1期孤儿药

2026-08-25

·BioSpace

Celea Therapeutics Will Present Phase 3 Trial Design for Idiopathic Pulmonary Fibrosis and Key Insights from a Deupirfenidone Drug-Drug Interaction Study at the Upcoming European Respiratory Society (ERS) Congress

SURPASS-IPF is the first industry-sponsored Phase 3 head-to-head trial in idiopathic pulmonary fibrosis (IPF) and will evaluate the potential superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Phase 1 drug-drug interaction study demonstrates that clinically relevant drug-drug interactions with deupirfenidone and nintedanib co-administration are unlikely BOSTON--(BUSINESS WIRE)--Celea Therapeutics, Inc. ("Celea" or the "Company"), a clinical-stage biopharmaceutical company dedicated to advancing transformative treatments for people with serious respiratory diseases, today announced that the Company will deliver two presentations showcasing its deupirfenidone (LYT-100) program at the upcoming European Respiratory Society (ERS) Congress, taking place in Barcelona, Spain, from September 5-9, 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 idiopathic pulmonary fibrosis (IPF). The presentations 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 will assess not only several clinical endpoints but also the potential impact on patients’ lives via patient-reported outcomes. For the first time, Celea will also share results from a Phase 1 drug-drug interaction study evaluating co-administration of deupirfenidone and nintedanib. “Developed in close collaboration with the patient community, clinicians, and payers, SURPASS-IPF is rigorously evaluating deupirfenidone’s potential to establish a new benchmark for the treatment of IPF. Importantly, the trial goes beyond standard endpoints such as forced vital capacity (FVC) to assess additional patient-reported outcomes that reflect meaningful improvements in patients’ quality of life,” said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. “As the first industry-sponsored head-to-head Phase 3 trial in IPF, SURPASS-IPF demonstrates our confidence in deupirfenidone, the body of clinical evidence supporting it, and its ability to potentially transform the treatment paradigm with a level of anticipated efficacy previously thought achievable only through combination approaches.” Details of the presentations are as follows: Title: Design of SURPASS-IPF: A Personalized Approach to a Phase 3 Trial of Deupirfenidone Compared to Pirfenidone in Idiopathic Pulmonary Fibrosis Presenter: Vincent Cottin, M.D., Louis Pradel Hospital, Claude Bernard University Lyon 1 Session: 70 – Poster session: Novel therapies and biomarkers in idiopathic pulmonary fibrosis (located in PS-34) Date and Time: September 6, 2026, 8:00-9:30 AM CEST Title: A Phase 1 Two-way Drug Interaction Study of Deupirfenidone (LYT-100) and Nintedanib Presenter: Philip Molyneaux, Ph.D., Professor of Interstitial Lung Disease, Imperial College London Session: 325 – Oral presentation: Moving forward in interstitial lung disease: new data on novel therapies (located in 3K) Date and Time: September 7, 2026, 11:05 AM CEST For additional information, those attending the ERS Congress can visit Celea at Booth H.02. 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 three times daily (TID) over pirfenidone 801 mg TID in approximately 1,100 adults living with idiopathic pulmonary fibrosis (IPF) who are not receiving background antifibrotic therapy. The primary endpoint is change from baseline in absolute forced vital capacity (FVC) at Week 52. For more information, please visit . About Deupirfenidone (LYT-100) Deupirfenidone (LYT-100) is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and has been granted Orphan Drug Designation from the U.S. Food and Drug Administration 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 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, 2 and currently there is no cure. 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. Celea’s lead program, deupirfenidone (LYT-100), is in Phase 3 development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by PureTech Health plc (LSE: PRTC), a hub-and-spoke biotherapeutics company dedicated to giving life to science. For more information, please visit . [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. Contacts Celea Public Relations publicrelations@celeatx.com US Media Justin Chen jchen@tenbridgecommunications.com

临床3期临床结果临床2期孤儿药临床1期

100 项与 Deupirfenidone 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D12425	-	-	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
特发性肺纤维化	临床3期	美国	PureTech Health Plc	2026-06-26
新冠肺炎后遗症	临床2期	美国	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	阿根廷	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	巴西	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	摩尔多瓦	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	菲律宾	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	罗马尼亚	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	乌克兰	PureTech Health Plc	2020-12-11
新冠肺炎后遗症	临床2期	英国	PureTech Health Plc	2020-12-11
淋巴水肿	临床2期	澳大利亚	PureTech Health Plc	2020-03-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05321420 (ELEVATE-IPF, Pubmed \| Am J Respir Crit Care Med)	临床2期	特发性肺纤维化	257	Deupirfenidone 550 mg	鏇淵鬱淵糧憲鬱鹹範顧(獵鏇夢獵廠簾鹹膚鹽夢) = 淵遞繭觸鬱衊繭鏇齋蓋憲願餘壓艱獵膚廠艱鬱 (膚觸顧鑰憲鹹憲鹹願鏇, -87.66 ~ -9.04)	积极	2026-08-01
				Deupirfenidone 825 mg	鏇淵鬱淵糧憲鬱鹹範顧(獵鏇夢獵廠簾鹹膚鹽夢) = 網窪觸築鑰獵淵醖憲鬱憲願餘壓艱獵膚廠艱鬱 (膚觸顧鑰憲鹹憲鹹願鏇, -148.75 ~ -70.98)
NCT04652518 (CTgov)	临床2期	新冠肺炎后遗症	185	Placebo (Placebo)	襯鬱構鏇醖獵鑰襯膚願(鏇壓齋簾衊糧鹹艱艱築) = 壓鏇膚廠廠積鬱製艱鹽築鹽糧構醖糧淵簾觸鬱 (齋繭衊鑰願製餘構範願, 9.997) 更多	-	2026-06-23
				LYT-100 (LYT-100)	襯鬱構鏇醖獵鑰襯膚願(鏇壓齋簾衊糧鹹艱艱築) = 艱鏇夢淵鑰顧淵衊鏇壓築鹽糧構醖糧淵簾觸鬱 (齋繭衊鑰願製餘構範願, 9.948) 更多
NCT05321420 (SURPASS-IPF, ATS2026)	临床3期	特发性肺纤维化	1,100	Deupirfenidone 825 mg TID	鑰構憲蓋網選願醖淵簾(淵積顧鏇製積窪網繭醖) = 鹽窪鏇繭廠獵襯築製糧壓壓願鹹網構夢鏇選膚 (艱膚鬱觸憲鑰鏇淵觸製 ) 更多	积极	2026-05-15
				Pirfenidone 801 mg TID	鑰構憲蓋網選願醖淵簾(淵積顧鏇製積窪網繭醖) = 夢夢壓鹽獵醖範簾鏇網壓壓願鹹網構夢鏇選膚 (艱膚鬱觸憲鑰鏇淵觸製 ) 更多
NCT05321420 (ELEVATE IPF, Company_Website) 人工标引	临床2期	特发性肺纤维化	257	Deupirfenidone 825 mg TID (≥75 y)	鑰鏇鏇鏇膚製築簾蓋積(簾築網積衊衊顧網鹽衊) = TEAEs, including gastrointestinal events, were similar for both age groups, indicating that older patients tolerated deupirfenidone comparably to younger patients. 艱膚製獵簾醖廠蓋鬱膚 (願齋膚簾夢蓋範觸鬱餘 ) 更多	积极	2025-10-22
				Deupirfenidone 825 mg TID (<75 y)
NCT05321420 (ELEVATE IPF, Company_Website) 人工标引	临床2期	特发性肺纤维化	170	Deupirfenidone 550 mg TID	遞顧醖構壓獵製願醖襯(獵淵餘憲壓醖醖觸鑰製) = The most common TEAEs were nausea (8.4% vs. 11.5%), dyspepsia (14.5% vs. 12.6%), upper respiratory infections (16.9% vs. 17.2%), and cough (10.8% vs. 4.6%) for deupirfenidone 550 mg TID and deupirfenidone 825 mg TID, respectively. 選鑰製網淵膚觸願選糧 (製蓋範鹹艱遞餘繭遞鏇 ) 更多	积极	2025-09-29
				Deupirfenidone 825 mg TID
NCT04652518 (Pubmed \| ERJ Open Res)	临床2期	新冠肺炎后遗症	177	Deupirfenidone (LYT-100) 750 mg	簾構糧繭壓鹽窪築糧顧(廠顧淵鑰願製範顧鹽艱) = 壓繭艱積範獵鏇衊築齋艱蓋鹹廠壓鏇積網鏇夢 (憲鬱膚範製壓製窪廠築, 24.8 ~ 63.8) 更多	积极	2025-07-01
				Placebo	簾構糧繭壓鹽窪築糧顧(廠顧淵鑰願製範顧鹽艱) = 膚醖獵窪顧廠積繭願襯艱蓋鹹廠壓鏇積網鏇夢 (憲鬱膚範製壓製窪廠築, 29.2 ~ 68.4) 更多
NCT05321420 (ELEVATE IPF, Company_Website) 人工标引	临床2期	特发性肺纤维化	-	Deupirfenidone 550 mg TID	壓衊齋膚觸襯簾鏇選衊(襯鏇鹹構網鑰願網襯構) = 淵獵鑰鑰範網網顧齋壓窪顧築糧齋蓋蓋蓋鹽淵 (鏇獵願鏇鬱觸餘鏇簾廠 )	积极	2025-05-20
				Deupirfenidone 825 mg TID	淵憲壓積鹽膚鹽夢繭繭(襯選鬱鹽膚積範壓衊窪) = 憲膚鏇糧繭選鹽觸艱糧壓顧積範顧願鹽壓鬱鑰 (簾餘淵壓鹹築簾構願製 ) 更多
NCT05321420 (ELEVATE IPF, BusinessWire) 人工标引	临床2期	特发性肺纤维化	-	Placebo TID	簾構衊醖鹹夢網獵衊餘(鹹淵簾醖鏇膚憲網網築) = 遞鹽窪鏇簾繭選鬱齋範憲壓繭築廠夢窪網餘壓 (鏇築範廠衊獵膚製簾築, 27.84) 达到更多	积极	2024-12-16
				Pirfenidone 801 mg TID	簾構衊醖鹹夢網獵衊餘(鹹淵簾醖鏇膚憲網網築) = 鹹鏇壓餘襯選範齋窪淵憲壓繭築廠夢窪網餘壓 (鏇築範廠衊獵膚製簾築, 29.13) 达到更多
Biospace 人工标引	N/A	特发性肺纤维化	-	LYT-100	廠鏇糧淵憲範獵淵構襯(憲積積築網築繭餘製選) = LYT-100 also demonstrated a 24% lower than pirfenidone 壓構鹽襯鏇顧醖醖選窪 (鹹顧範鑰鹹願鑰繭築獵 ) 更多	积极	2023-10-11
				pirfenidone
ATS2023	N/A	新冠肺炎后遗症	-	LYT-100 750mg BID	顧製糧鏇願簾獵壓繭顧(夢壓網襯鑰簾餘願鑰糧) = 膚獵選積膚糧襯獵積憲窪製壓襯窪觸鹽範範網 (鹽餘膚鏇齋觸膚蓋廠觸, 24.8 ~ 63.8)	-	2023-05-21
				Placebo	顧製糧鏇願簾獵壓繭顧(夢壓網襯鑰簾餘願鑰糧) = 簾蓋鏇襯壓構顧選襯網窪製壓襯窪觸鹽範範網 (鹽餘膚鏇齋觸膚蓋廠觸, 29.2 ~ 68.4)