Transforming care for people living with idiopathic pulmonary fibrosis (IPF)
Celea Therapeutics is advancing deupirfenidone, a novel therapy with the potential to set a new standard of care for this progressive and life-threatening lung disease.
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Deupirfenidone Snapshot
A Potential New Standard
of Care
Deupirfenidone (LYT-100) is an investigational therapy being developed as a potential new standard of care (SOC) for idiopathic pulmonary fibrosis (IPF).
In a global Phase 2b trial, deupirfenidone stabilized lung function decline to levels expected in healthy older adults with a favorable safety and tolerability profile.
Based on these positive results, Celea is advancing deupirfenidone into a pivotal Phase 3 trial, which is expected to initiate in the first half of 2026.
INDICATION:
MEDICATION:
Oral tablet, three times a day
CLINICAL PROGRESS:
Completed: Phase 2b Clinical Trial (Part A) Summary
Deupirfenidone demonstrated the potential to stabilize lung function decline over at least 26 weeks while maintaining a favorable safety and tolerability profile.
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Deupirfenidone 825 mg three times a day (TID) demonstrated a forced vital capacity (FVC) decline of -21.5 mL over 26 weeks, approaching the natural lung function decline expected in healthy older adults over the same period of time.
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Deupirfenidone 825 mg three times a day (TID) demonstrated an approximately 50% greater treatment effect than the FDA-approved pirfenidone 801 mg TID (80.9% vs 54.1%, respectively) when compared to placebo over 26 weeks.
The treatment effect reflects how much better patients did on therapy compared to taking no treatment. In this study, deupirfenidone showed an 80.9% improvement versus placebo, while pirfenidone showed a 54.1% improvement.
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Pharmacokinetic (PK) data demonstrate that treatment with deupirfenidone 825 mg three times a day (TID) achieved approximately 50% higher drug exposure than pirfenidone 801 mg TID. In practical terms, this means a patient taking a tablet of deupirfenidone 825 mg receives about 50% more active medication than a patient taking pirfenidone 801 mg.
Importantly, this increased exposure did not result in additional tolerability challenges, suggesting that the deuterated structure of deupirfenidone may help overcome the dose-limiting adverse events associated with pirfenidone. These PK results are consistent with the enhanced efficacy and favorable tolerability observed with deupirfenidone 825 mg TID in the Phase 2b trial.
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Both doses of deupirfenidone were generally well-tolerated in the trial. Overall, the number of participants experiencing any gastrointestinal (GI)-related adverse events (AEs) was similar across the deupirfenidone 825 mg TID and pirfenidone 801 mg TID arms.
A lower percentage of patients in the deupirfenidone 825 mg TID arm reported experiencing key GI AEs compared to the pirfenidone 801 mg TID arm: nausea (20.3% vs. 27.0%), dyspepsia (14.1% vs. 22.2%), diarrhea (7.8% vs. 11.1%), constipation (4.7% vs. 6.3%) and vomiting (1.6% vs. 3.2%). The only key GI AE increase observed was abdominal pain (14.1% vs. 7.9%).
Ongoing: Open-label Extension (OLE) Trial (Part B)
Data from the ongoing open-label extension study support durability of the treatment effect seen in Part A over at least 52 weeks.
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Patients who remained on 825 mg three times a day (TID) in both Part A and Part B experienced an overall forced vital capacity (FVC) decline of -32.8 mL over the 52-week period, approaching the natural lung function decline expected in healthy older adults over the same period of time.
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Patients who received placebo or pirfenidone in Part A and switched to deupirfenidone in Part B achieved lung function stabilization. These Part B data were similar to the results demonstrated with deupirfenidone 825 mg three times a day (TID) in Part A, further reinforcing the consistency of the treatment effect.
Phase 3 trial initiation expected in the first half of 2026
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About Idiopathic Pulmonary Fibrosis
Idiopathic pulmonary fibrosis (IPF) is a rare and serious lung disease in which the tissue deep inside the lungs becomes thickened and scarred over time. This scarring, known as fibrosis, makes it increasingly difficult for the lungs to work properly and for the body to get enough oxygen.
People living with IPF often experience shortness of breath, a dry cough, and fatigue that worsen as the disease progresses. IPF is considered a progressive and ultimately fatal condition, meaning it gradually gets worse and can lead to respiratory failure. There is currently no cure. Celea Therapeutics is working to rapidly advance deupirfenidone as a potential new treatment option for people living with IPF.
Untold Experiences of People Living with IPF
As part of our commitment to the IPF community, we’ve identified critical barriers to treatment, opportunities for improved community engagement, and the need for patient-centered approaches in the development of new therapeutics. These learnings, captured in this publication, are being incorporated into our future development plans for deupirfenidone.
This study was conducted in collaboration with Tejaswini Kulkarni, MD, MPH, from the University of Alabama at Birmingham, Lisa Lancaster, MD, from Vanderbilt University Medical Center, and Jessica Shore, RN, PhD, from the Pulmonary Fibrosis Foundation (PFF).
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 and is currently a wholly-owned subsidiary of PureTech Health plc (LSE, Nasdaq: PRTC), a biotherapeutics company dedicated to giving life to science. PureTech's innovative hub-and-spoke 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.