Celea Therapeutics Doses First Patient in Global Phase 3 SURPASS-IPF Trial Evaluating Deupirfenidone for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
Celea Therapeutics Doses First Patient in Global Phase 3 SURPASS-IPF Trial Evaluating Deupirfenidone for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)
July 13, 2026
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 profile of 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 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.
_____________________________
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.
Contact:
Celea
Public Relations
publicrelations@celeatx.com
US Media
Justin Chen
jchen@tenbridgecommunications.com
Celea Therapeutics Announces $180 Million Financing to Advance Deupirfenidone as a Potential New Standard of Care to Treat Idiopathic Pulmonary Fibrosis (IPF)
Celea Therapeutics Announces $180 Million Financing to Advance Deupirfenidone as a Potential New Standard of Care to Treat Idiopathic Pulmonary Fibrosis (IPF)
July 2, 2026
Financing brings together a syndicate of top-tier healthcare investors, including RA Capital Management, Leaps by Bayer, and Celea founder PureTech Health, alongside a large, US-based healthcare-focused fund and a leading sovereign wealth fund
Proceeds will enable early Q3 2026 initiation of SURPASS-IPF, the first head-to-head Phase 3 trial in IPF, evaluating superiority of deupirfenidone vs. pirfenidone
BOSTON-Celea Therapeutics ("Celea" or the "Company"), a clinical-stage biopharmaceutical company dedicated to advancing transformative treatments for people with serious respiratory diseases, today announced the completion of a $180 million financing. Participants included RA Capital Management, Leaps by Bayer, and founder PureTech Health (LSE: PRTC), alongside a large, U.S.-based healthcare-focused fund and a leading sovereign wealth fund. Proceeds from the financing will support the planned early Q3 2026 initiation of the Phase 3 SURPASS-IPF trial of deupirfenidone (LYT-100), an investigational next-generation antifibrotic with the potential to serve as a new standard of care for people living with idiopathic pulmonary fibrosis (IPF).
"People living with IPF continue to face a devastating disease with limited treatment options, and we believe deupirfenidone has the potential to deliver meaningful improvements for patients," said Sven Dethlefs, Ph.D., Chief Executive Officer of Celea. "We are grateful for the support and confidence of this exceptional group of investors, whose commitment enables us to initiate the Phase 3 SURPASS-IPF trial and advance development of deupirfenidone with the speed and focus this community deserves."
"We are delighted to support Celea as it enters this important next stage of development,” said Laura Stoppel, Ph.D., Partner at RA Capital Management. “The compelling results generated to date with deupirfenidone and the Company’s bold Phase 3 SURPASS-IPF trial represent a differentiated opportunity to meaningfully change the treatment landscape in IPF. Supported by a seasoned team with a demonstrated track record of successfully advancing innovative medicines, Celea is exceptionally well positioned to execute on its strategy of unlocking the full potential of deupirfenidone for patients.”
The planned pivotal Phase 3 SURPASS-IPF trial is a global, randomized, double-blind, head-to-head trial directly comparing deupirfenidone 825 mg TID to pirfenidone 801 mg TID in adults with IPF who are not on background therapy. The primary efficacy endpoint is the change from baseline in absolute forced vital capacity at week 52, which will assess the superiority of deupirfenidone compared with pirfenidone. Celea expects to initiate the Phase 3 SURPASS-IPF trial in early Q3 2026.
About Deupirfenidone (LYT-100)
Deupirfenidone (LYT-100) is in development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF) 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 inThe 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 a Phase 3-ready therapeutic candidate with the potential to set a new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea was founded by 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.
_____________________________
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.
Contact:
Celea
Public Relations
publicrelations@celeatx.com
US Media
Justin Chen
jchen@tenbridgecommunications.com
PureTech Announces the Launch of Celea Therapeutics with a Mission to Transform the Treatment of Respiratory Diseases
PureTech Announces the Launch of Celea Therapeutics with a Mission to Transform the Treatment of Respiratory Diseases
Former Teva North America CEO Sven Dethlefs, PhD, to lead Celea
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced the launch of a new Founded Entity Celea Therapeutics ("Celea").
Celea's mission is to deliver therapies that transform the lives of people with serious respiratory diseases. Its lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate that holds promise across multiple fibrotic and inflammatory lung conditions and is initially being advanced for the treatment of idiopathic pulmonary fibrosis (IPF), a rare, progressive, and fatal lung disease. Sven Dethlefs, PhD, has been appointed to lead Celea, bringing deep expertise and a clear vision to accelerate the program's advancement. The launch of Celea reflects PureTech's commitment to advancing differentiated programs through focused, capital-efficient structures with seasoned leadership.
Dr. Dethlefs is a proven pharmaceutical executive with more than 25 years of experience in global commercialization, R&D strategy, business development, and operations. He has played a central role at PureTech, driving forward the deupirfenidone program for more than a year. Prior to joining PureTech, Dr. Dethlefs served as CEO of Teva North America, where he oversaw the company's $8 billion specialty branded and generic businesses across the U.S. and Canada. At Teva, he also held senior leadership roles as Global Head of Marketing and Portfolio, Head of Respiratory Medicines, and COO Operations. He played a key role in the successful launch of AUSTEDO®, Teva's blockbuster treatment for Tardive Dyskinesia and Huntington's Disease, which is a deuterated form of tetrabenazine. Prior to joining Teva, Dr. Dethlefs was a partner at McKinsey & Company. He holds a PhD in Biochemistry.
Dr. Sven Dethlefs commented: "Bringing meaningful innovation to patients with serious diseases has been a consistent theme throughout my career, and I believe deupirfenidone has the potential to be a true turning point in the treatment of IPF. Our Phase 2b data demonstrated the potential for best-in-class efficacy with a favorable safety and tolerability profile-addressing two of the most critical limitations of current therapies. The strength of the clinical data, combined with the team and mission behind Celea, make this a uniquely compelling opportunity. I'm excited to lead the next phase of development as we work to deliver a new standard of care for people living with IPF and other debilitating lung conditions."
PureTech completed a successful Phase 2b trial of deupirfenidone in December 2024. A meeting with the U.S. Food and Drug Administration to discuss these results and the proposed Phase 3 trial design is expected by the end of the third quarter of 2025. Consistent with its capital-efficient innovation model, PureTech is pursuing third-party funding for Celea to advance the program through Phase 3 and potential commercialization.
Robert Lyne, PureTech's Interim Chief Executive Officer, added: "The launch of Celea is an important value driver for PureTech. Sven brings deep experience in respiratory medicine and a strong track record of commercial success, including having played a critical role in the growth of AUSTEDO®, a deuterated medicine developed using the same underlying chemistry approach as deupirfenidone. He is uniquely suited to lead Celea and advance this important program."
About Deupirfenidone (LYT-100)
Deupirfenidone (LYT-100) is in development as a potential new standard of care for the treatment of idiopathic pulmonary fibrosis (IPF). It is a deuterated form of pirfenidone, which - along with nintedanib - is one of the two FDA-approved treatments for IPF. Both approved therapies offer only modest efficacy in slowing lung function decline, largely due to tolerability challenges that limit the ability to achieve higher doses that could significantly improve patient outcomes. These limitations have contributed to low treatment uptake and poor adherence, with approximately 25% of people with IPF in the U.S. ever receiving either drug. Despite this, combined peak global sales exceed $5 billion, representing a significant market opportunity in IPF and other fibrotic lung diseases. [1]
Deupirfenidone may overcome these limitations. In the global Phase 2b ELEVATE IPF trial, deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks as a monotherapy while maintaining a favorable safety and tolerability profile. Initial data from an ongoing open-label extension study suggest that this effect may be sustained through at least 52 weeks. These findings support the potential for deupirfenidone to offer a meaningful advance for people living with this progressive and deadly disease. Beyond IPF, deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases.
About Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic pulmonary fibrosis (IPF) is a rare, progressive, and fatal lung disease characterized by irreversible scarring of lung tissue that leads to a steady decline in lung function. Median survival following diagnosis is estimated to be two to five years, and currently there is no cure.[2]
About Celea Therapeutics
Celea Therapeutics is dedicated to delivering transformative treatments for people with serious respiratory diseases. The company's lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate with the potential to set a new standard of care for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases.
Celea was founded by PureTech Health plc (Nasdaq: PRTC, LSE: PRTC), a biotherapeutics company dedicated to giving life to science. PureTech's innovative R&D model drives the creation of Founded Entities like Celea, enabling the advancement of highly promising medicines to patients in a capital-efficient manner. For more information, please visit www.celeatx.com and www.puretechhealth.com.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated to giving life to new classes of medicine to change the lives of patients with devastating diseases. The Company has created a broad and deep portfolio through its experienced research and development team and its extensive network of scientists, clinicians, and industry leaders that is being advanced both internally and through its Founded Entities. PureTech's R&D engine has resulted in the development of 29 therapeutics and therapeutic candidates, including three that have been approved by the U.S. Food and Drug Administration. A number of these programs are being advanced by PureTech or its Founded Entities in various indications and stages of clinical development, including registration-enabling studies. All of the underlying programs and platforms that resulted in this portfolio of therapeutic candidates were initially identified or discovered and then advanced by the PureTech team through key validation points.
For more information, visit www.puretechhealth.com or connect with us on X (formerly Twitter) @puretechh.
Cautionary Note Regarding Forward-Looking Statements
This press release contains statements that are or may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements that relate to continued development of and regulatory interactions related to deupirfenidone, the potential of deupirfenidone in IPF and other indications, our expectations around our therapeutic candidates and approach towards addressing major diseases, our plans to advance our programs and deliver on our milestones, our future plans, prospects, developments, and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks, uncertainties and other important factors that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks, uncertainties and other important factors described under the caption "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2024 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
US Media
Justin Chen
+1 609 578 7230
justin@tenbridgecommunications.com
[1] Esbriet peak sales (2020) per Roche 2021 Financial Results & Ofev peak sales (2024) per Boehringer Ingelheim 2024 Financial Results. Ofev sales include those for all approved indications - IPF, PF-ILD, and systemic sclerosis-associated interstitial lung disease (SSc-ILD).
[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. https://doi.org/10.18553/jmcp.2017.23.3-b.s17
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