Deupirfenidone

SURPASS-IPF is the first industry-sponsored head-to-head Phase 3 trial in IPF and will evaluate the superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Topline data expected in the second half of 2029 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 the first patient has been dosed in the global Phase 3 SURPASS-IPF trial evaluating the superiority of deupirfenidone 825 mg three times daily (TID) vs. pirfenidone 801 mg TID for the treatment of idiopathic pulmonary fibrosis (IPF). The commencement of the potentially registrational Phase 3 trial follows the recent completion of Celea’s $180 million financing , which enables the continued advancement of deupirfenidone as a potential new standard of care for people living with IPF. Robert Lyne, Chief Executive Officer of PureTech commented: "The initiation of SURPASS-IPF marks another important milestone for both PureTech and Celea. Just days after the completion of Celea's financing, the first patient has now been dosed in the first industry-sponsored head-to-head Phase 3 trial in IPF. This rapid progression reflects the strength of the clinical, regulatory, and operational foundation established for the program and the team’s ability to execute as deupirfenidone enters this important stage of development.” The full text of the announcement from Celea is as follows: Celea Therapeutics Doses First Patient in Global Phase 3 SURPASS-IPF Trial Evaluating Deupirfenidone for the Treatment of Idiopathic Pulmonary Fibrosis (IPF) SURPASS-IPF is the first industry-sponsored head-to-head Phase 3 trial in IPF and will evaluate the superiority of deupirfenidone 825 mg TID vs. pirfenidone 801 mg TID Topline data expected in the second half of 2029 BOSTON, July 13, 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 first patient has been dosed in the global Phase 3 SURPASS-IPF trial evaluating the superiority of deupirfenidone 825 mg three times daily (TID) vs. pirfenidone 801 mg TID for the treatment of idiopathic pulmonary fibrosis (IPF). The commencement of the potentially registrational Phase 3 trial follows Celea’s recently completed $180 million financing , enabling the Company to rapidly advance development of deupirfenidone as a potential new standard of care for the treatment of IPF. "The speed with which we have progressed from completing our financing to dosing the first patient in SURPASS-IPF reflects the extensive preparation that preceded this milestone, the strength of our organization, and our unwavering focus on execution," said Sven Dethlefs, PhD, Chief Executive Officer of Celea. “We designed SURPASS-IPF as the first industry-sponsored Phase 3 trial in IPF to evaluate superiority over an approved antifibrotic because we believe deupirfenidone has the potential to achieve a level of efficacy once thought attainable only through combination approaches, while maintaining a favorable tolerability profile. This milestone represents an important step toward delivering a truly differentiated treatment option for people living with this devastating disease." The pivotal Phase 3 SURPASS-IPF trial is a global, randomized, double-blind, head-to-head trial comparing deupirfenidone 825 mg TID to pirfenidone 801 mg TID over 52 weeks in adults living with IPF who are not receiving background antifibrotic therapy. The trial is designed to evaluate the superiority of deupirfenidone 825 mg TID over pirfenidone 801 mg TID, using change from baseline in absolute forced vital capacity (FVC) as the primary endpoint, while also further characterizing the overall safety and tolerability pro deupirfenidone 825 mg TID. The trial is expected to enroll approximately 1,100 people living with IPF across more than 30 countries. "I’m proud that our site was able to dose the first patient in the SURPASS-IPF trial,” said Rafael Lupercio, M.D., Pulmonologist at Shasta Critical Care Specialists in Redding, CA, and an investigator in the SURPASS-IPF trial. “When discussing clinical trial participation with people living with IPF, study design matters. What stands out to me about SURPASS-IPF is that it directly compares deupirfenidone to an approved antifibrotic. Knowing that every participant will receive active treatment is an important consideration in a disease as serious and progressive as IPF. As both an investigator and a treating physician, I believe this trial has the potential to generate the type of evidence that will be highly meaningful to people living with IPF and the clinicians who care for them.” SURPASS-IPF builds upon the strong results from the global Phase 2b ELEVATE-IPF trial and open-label extension, which together demonstrated the potential for deupirfenidone to substantially reduce lung function decline toward the rate expected with normal physiological aging in healthy older adults over at least 52 weeks, while maintaining a favorable safety and tolerability profile. The Phase 3 trial employs the same active comparator and dosing regimen evaluated in Phase 2b, providing continuity across the clinical development program while expanding evaluation to a larger, global patient population. "We applaud Celea's commitment to advancing care for those impacted by IPF," said Scott Staszak, President and CEO of the Pulmonary Fibrosis Foundation. "Celea’s Phase 3 SURPASS-IPF trial represents an important step forward for the IPF community and strengthens the path toward more effective treatment options while reflecting the priorities of people living with IPF." SURPASS-IPF was designed to generate robust, high-confidence data while ensuring the clinical trial experience prioritizes patient needs. The trial does not include a placebo arm and instead compares deupirfenidone 825 mg TID directly with an approved standard-of-care therapy, pirfenidone 801 mg TID. This approach ensures that all participants receive active treatment—an important consideration in a progressive and irreversible disease such as IPF. This patient-centric approach builds upon the design principles established in the Phase 2b ELEVATE-IPF trial, which minimized unnecessary placebo exposure duration while generating robust clinical evidence. "As a physician-scientist, I've seen firsthand how difficult treatment decisions can be for people living with IPF and the physicians who care for them," said Camilla Graham, MD, MPH, Senior Vice President of Medical Affairs at Celea. "SURPASS-IPF was designed to answer the question that matters most in clinical practice: can we meaningfully improve upon today's standard of care? Building on the encouraging efficacy and tolerability observed in Phase 2b, this trial has the potential to generate the robust evidence needed to inform future treatment decisions and, ultimately, improve outcomes for people living with IPF." Topline results from the Phase 3 SURPASS-IPF trial are expected in the second half of 2029. Based on feedback from the FDA, results from this single Phase 3 trial, supported by the totality of data from the overall deupirfenidone development program, could complete the data package required to support potential registration of deupirfenidone in the U.S. 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