Data presented at the CHEST 2025 Annual Meeting highlight deupirfenidone’s differentiated profile and potential to address unmet needs across age groups

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value, today announced the presentation of new analyses from the Phase 2b ELEVATE IPF trial of deupirfenidone (LYT-100) for the treatment of idiopathic pulmonary fibrosis (IPF). The data show that the favorable safety and efficacy profile of deupirfenidone was consistent across age groups, including in patients aged 75 years and older. These findings, presented at the American College of Chest Physicians (CHEST) 2025 Annual Meeting, suggest that deupirfenidone may address a key gap in the treatment of IPF, as older patients have historically been less likely to be treated, largely due to tolerability challenges.^1,2 These data further reinforce deupirfenidone’s differentiated profile and support its potential to meaningfully improve care for this vulnerable population.

“These data are a welcome indication that age does not necessarily translate to a poorer treatment experience in IPF, which is generally a disease of older people,” said Tejaswini Kulkarni, MD, MPH, Associate Professor of Pulmonary, Allergy and Critical Care Medicine at the University of Alabama at Birmingham, who presented the data at CHEST 2025. “Older people with IPF have historically been undertreated and underrepresented in clinical trials because antifibrotic medications can be especially difficult to tolerate for this demographic. Demonstrating consistent safety and efficacy, particularly in this population, reinforces the differentiated profile of deupirfenidone and its potential to benefit a broad range of patients living with IPF.”

ELEVATE IPF was a randomized, double-blind, active- and placebo-controlled Phase 2b trial evaluating deupirfenidone 825 mg TID and deupirfenidone 550 mg TID compared to placebo and pirfenidone 801 mg TID in patients with IPF. This sub-analysis primarily focused on safety and tolerability in patients aged ≥75 years (n=91) compared with those aged <75 years (n=166), as tolerability challenges are a primary barrier to treatment in older populations. Treatment emergent adverse events, including gastrointestinal events, were similar for both age groups, indicating that older patients tolerated deupirfenidone comparably to younger patients. For example, the rates of nausea in patients aged ≥75 years vs. <75 years were 18.2% vs. 21.4% for deupirfenidone 825 mg TID; 14.3% vs. 18.2% for deupirfenidone 550 mg TID; 25.9% vs. 27.8% for pirfenidone 801 mg TID; and 9.5% vs. 6.8% for placebo. Efficacy also remained consistent with previously reported results, providing additional support for deupirfenidone’s differentiated profile in this patient population.

“Older patients represent a large and growing segment of the IPF population, yet they’ve historically been less likely to receive treatment due to concerns around tolerability,” said Camilla Graham, MD, MPH, Senior Vice President of Medical Affairs at PureTech. “These findings highlight deupirfenidone’s potential to be an attractive treatment option for a broader range of patients, including those who have often been underserved, while maintaining the strong efficacy profile demonstrated in the Phase 2b trial.”

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 next generation antifibrotic and a deuterated form of pirfenidone, one of three FDA-approved therapies for IPF. The uptake 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 2019.³

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 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.⁴

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. 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 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 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.

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