IL-6 inhibitors(Interleukin-6 inhibitors), TGF-β inhibitors(Transforming growth factor beta inhibitors), TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Respiratory DiseasesOther Diseases

Active Indication

Idiopathic Pulmonary Fibrosis

Inactive Indication

LymphedemaPost Acute COVID 19 Syndrome

Originator Organization

Teva Pharmaceutical Industries Ltd.

Active Organization

PureTech Health Plc

IQVIA RDS (Shanghai) Co. Ltd.

Teva Pharmaceutical Industries Ltd.

+ [1]

Inactive Organization-

License Organization

Auspex Pharmaceuticals, Inc.

PureTech Health Plc

Drug Highest PhasePhase 3

First Approval Date-

RegulationOrphan Drug (United States), Orphan Drug (European Union)

Structure/Sequence

Molecular FormulaC12H11NO

InChIKeyISWRGOKTTBVCFA-FIBGUPNXSA-N

CAS Registry1093951-85-9

Clinical Trials associated with Deupirfenidone

NCT07284602

/ RecruitingPhase 3

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.

Start Date26 Jun 2026

Sponsor / Collaborator

PureTech Health Plc

CTRI/2023/02/050138

/ RecruitingPhase 2

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).

Start Date30 Mar 2023

Sponsor / Collaborator

Puretech LYT, Inc.

NCT05321420

/ Active, not recruitingPhase 2

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.

Start Date22 Jul 2022

Sponsor / Collaborator

PureTech Health Plc

100 Clinical Results associated with Deupirfenidone

100 Translational Medicine associated with Deupirfenidone

100 Patents (Medical) associated with Deupirfenidone

Literatures (Medical) associated with Deupirfenidone

01 Aug 2026·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.

01 Mar 2026·ERJ Open Research

A phase 1 pharmacokinetics study of deupirfenidone (LYT-100) in healthy older adults

Article

Author: Michael C. Chen ; Camilla S. Graham ; Eric Elenko ; Chris C. Korth ; Toby M. Maher ; Mark D. Harnett ; Varun Garg

Background:

Deupirfenidone, a selectively deuterated form of pirfenidone, is being developed for idiopathic pulmonary fibrosis (IPF), where tolerability limits current antifibrotic use. Deupirfenidone retains the biological activity of pirfenidone, and the differentiated pharmacokinetic (PK) profile may be associated with improved tolerability.

Methods:

A phase 1, three-part, randomised, double-blind study was conducted to identify phase 2 doses. The safety, tolerability, steady-state PK and food effect profile of deupirfenidone were assessed in healthy older adults. Part 1 was a crossover study comparing deupirfenidone 850 mg twice daily to pirfenidone 801 mg three times daily. Part 2 was a crossover study comparing deupirfenidone 550 mg three times daily to pirfenidone 801 mg three times daily. Part 3 was a parallel study of deupirfenidone 550 mg three times daily titrated to deupirfenidone 824 mg three times daily versus placebo.

Results:

Deupirfenidone 850 mg twice daily met the equivalence criterion to pirfenidone 801 mg three times daily for area-under-the-curve (AUC); however, maximum measured concentration ( Cmax ) and treatment-emergent adverse events (TEAEs) were higher with deupirfenidone. Deupirfenidone 550 mg three times daily met equivalence criterion to pirfenidone 801 mg three times daily for AUC; however, Cmax was lower. Frequency of gastrointestinal (GI) and nervous system (NS) TEAEs for deupirfenidone in the fed state was 40% lower than for pirfenidone. When deupirfenidone was titrated from 550 mg three times daily to 824 mg three times daily, PK parameters increased without increases in GI or NS TEAEs.

Conclusions:

Results suggest evaluating a dose for deupirfenidone in healthy older adults of between 550 mg three times daily and 825 mg three times daily. Both doses are being evaluated in a 26-week, phase 2b study in patients with IPF.

01 Jul 2025·ERJ Open Research

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

Article

Author: Harnett, Mark ; Santiaguel, Joel ; Krop, Julie ; Chen, Michael C ; Kulkarni, Tejaswini ; Aul, Raminder ; 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.

News (Medical) associated with Deupirfenidone

30 Sep 2026

·www.biospace.com

Celea Therapeutics Presents SURPASS-IPF Phase 3 Trial Design and Statistical Considerations for Evaluating Clinical Trials in Idiopathic Pulmonary Fibrosis at the IPF Summit 2026

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 . 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. ____________________ [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 Information info@celeatx.com US Media Justin Chen TBCCelea@tenbridgecommunications.com

Phase 3Phase 2Clinical ResultOrphan Drug

25 Aug 2026

·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

Phase 3Clinical ResultPhase 1Phase 2Orphan Drug

25 Aug 2026

·www.biospace.com

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

Phase 3Clinical ResultPhase 2Phase 1Orphan Drug

100 Deals associated with Deupirfenidone

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D12425	-	-	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	Phase 3	United States	PureTech Health Plc	26 Jun 2026
Idiopathic Pulmonary Fibrosis	Phase 3	Canada	PureTech Health Plc	26 Jun 2026
Post Acute COVID 19 Syndrome	Phase 2	United States	PureTech Health Plc	11 Dec 2020
Post Acute COVID 19 Syndrome	Phase 2	Argentina	PureTech Health Plc	11 Dec 2020
Post Acute COVID 19 Syndrome	Phase 2	Brazil	PureTech Health Plc	11 Dec 2020
Post Acute COVID 19 Syndrome	Phase 2	Moldova	PureTech Health Plc	11 Dec 2020
Post Acute COVID 19 Syndrome	Phase 2	Philippines	PureTech Health Plc	11 Dec 2020
Post Acute COVID 19 Syndrome	Phase 2	Romania	PureTech Health Plc	11 Dec 2020
Post Acute COVID 19 Syndrome	Phase 2	Ukraine	PureTech Health Plc	11 Dec 2020
Post Acute COVID 19 Syndrome	Phase 2	United Kingdom	PureTech Health Plc	11 Dec 2020

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05321420 (ELEVATE-IPF, Pubmed \| Am J Respir Crit Care Med)	Phase 2	Idiopathic Pulmonary Fibrosis	257	Deupirfenidone 550 mg	vvyxkycdcq(shbeftsqkl) = ppcfcxzvru twxrcvsrjb (eqsctvnvjt, -87.66 to -9.04)	Positive	01 Aug 2026
				Deupirfenidone 825 mg	vvyxkycdcq(shbeftsqkl) = ckswbtpxqb twxrcvsrjb (eqsctvnvjt, -148.75 to -70.98)
NCT04652518 (CTgov)	Phase 2	Post Acute COVID 19 Syndrome	185	Placebo (Placebo)	btejygvvzi(heoqsjeztc) = opsxuqcfsd zhkdeikehp (vrbwekrkpm, 9.997) View more	-	23 Jun 2026
				LYT-100 (LYT-100)	btejygvvzi(heoqsjeztc) = dvhvypltzt zhkdeikehp (vrbwekrkpm, 9.948) View more
NCT05321420 (SURPASS-IPF, ATS2026)	Phase 3	Idiopathic Pulmonary Fibrosis	1,100	Deupirfenidone 825 mg TID	vtckueiuwu(pbxbsyeyuw) = mgmyhtrcek ajiodwqdtm (nxqapuqgvz ) View more	Positive	15 May 2026
				Pirfenidone 801 mg TID	vtckueiuwu(pbxbsyeyuw) = rvdoliohet ajiodwqdtm (nxqapuqgvz ) View more
NCT05321420 (ELEVATE IPF, Company_Website) Manual	Phase 2	Idiopathic Pulmonary Fibrosis	257	Deupirfenidone 825 mg TID (≥75 y)	djjpizxdqh(pwlacitvbf) = TEAEs, including gastrointestinal events, were similar for both age groups, indicating that older patients tolerated deupirfenidone comparably to younger patients. xkoedgeoad (wupgmngolc ) View more	Positive	22 Oct 2025
				Deupirfenidone 825 mg TID (<75 y)
NCT05321420 (ELEVATE IPF, Company_Website) Manual	Phase 2	Idiopathic Pulmonary Fibrosis	170	Deupirfenidone 550 mg TID	pnjyjmmqcg(tyvvsvbfou) = 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. qnykriskzi (plwltngruc ) View more	Positive	29 Sep 2025
				Deupirfenidone 825 mg TID
NCT04652518 (Pubmed \| ERJ Open Res)	Phase 2	Post Acute COVID 19 Syndrome	177	Deupirfenidone (LYT-100) 750 mg	nlmgfcayqp(gnhcsnpden) = fkvtoiseqv blgphortsk (ezbwnxoouk, 24.8 - 63.8) View more	Positive	01 Jul 2025
				Placebo	nlmgfcayqp(gnhcsnpden) = lsuqnmdupy blgphortsk (ezbwnxoouk, 29.2 - 68.4) View more
NCT05321420 (ELEVATE IPF, Company_Website) Manual	Phase 2	Idiopathic Pulmonary Fibrosis	-	Deupirfenidone 550 mg TID	urxyeztpzx(nejtmxyhng) = xkguarsdyu pcudsgvuiz (keafvhprii )	Positive	20 May 2025
				Deupirfenidone 825 mg TID	gbegqewqtr(yhadyjznxz) = bpuhotrcwe ijomrrmqvq (gfuovxthpd ) View more
NCT05321420 (ELEVATE IPF, BusinessWire) Manual	Phase 2	Idiopathic Pulmonary Fibrosis	-	Placebo TID	cqfefjbqfw(wzjvlyyumu) = hbuawvythp sjqzfwhrkt (lnwenberlu, 27.84) Met View more	Positive	16 Dec 2024
				Pirfenidone 801 mg TID	cqfefjbqfw(wzjvlyyumu) = nyqwyucbvt sjqzfwhrkt (lnwenberlu, 29.13) Met View more
Biospace Manual	Not Applicable	Idiopathic Pulmonary Fibrosis	-	LYT-100	ipldhltvgo(gvdurggkut) = LYT-100 also demonstrated a 24% lower than pirfenidone jvupfotdsu (fvizlafjrm ) View more	Positive	11 Oct 2023
				pirfenidone
ATS2023	Not Applicable	Post Acute COVID 19 Syndrome	-	LYT-100 750mg BID	rbhnyasonf(kwoihyeuby) = dngmwejfcu eynpjtbruk (mramhsladv, 24.8 - 63.8)	-	21 May 2023
				Placebo	rbhnyasonf(kwoihyeuby) = qwulzviuez eynpjtbruk (mramhsladv, 29.2 - 68.4)

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