Celea Therapeutics Doses First Patient in Global Phase 3 Trial for Idiopathic Pulmonary Fibrosis Treatment

Celea Therapeutics has announced that the first patient has been dosed in its global Phase 3 SURPASS-IPF clinical trial evaluating deupirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF).

The study will compare deupirfenidone 825 mg taken three times daily with pirfenidone 801 mg taken three times daily, an approved treatment for IPF. The company hopes the investigational therapy can become a new standard of care for people living with this serious lung disease.

The launch of the Phase 3 trial comes shortly after Celea completed a $180 million financing round to support the continued development of deupirfenidone.

Trial Will Compare Two Active Treatments

SURPASS-IPF is a global, randomized, double-blind Phase 3 study designed to compare deupirfenidone directly with pirfenidone over a treatment period of 52 weeks.

Unlike many large clinical studies, this trial does not include a placebo group. Every participant will receive an active treatment, which the company believes is especially important for patients living with a progressive disease like IPF.

Researchers will measure changes in forced vital capacity (FVC), a common test used to evaluate lung function, as the primary endpoint. The study will also continue to assess the overall safety and tolerability of deupirfenidone.

Around 1,100 adults with idiopathic pulmonary fibrosis are expected to participate across more than 30 countries.

Company Aims to Improve Current Standard of Care

Sven Dethlefs, Chief Executive Officer of Celea Therapeutics, said the company has moved quickly from securing funding to enrolling the first patient because of extensive preparation and a strong focus on execution.

He explained that SURPASS-IPF is the first industry-sponsored Phase 3 trial in idiopathic pulmonary fibrosis designed to demonstrate superiority over an already approved antifibrotic therapy.

According to him, the company believes deupirfenidone has the potential to deliver stronger efficacy while maintaining a favorable tolerability profile, something that has been difficult to achieve with currently available treatments.

Study Builds on Encouraging Phase 2 Results

The Phase 3 program follows positive findings from the global Phase 2b ELEVATE-IPF study and its open-label extension.

Earlier clinical data suggested that deupirfenidone may substantially slow the decline in lung function, bringing it closer to the rate of normal aging in healthy older adults.

The treatment also demonstrated a favorable safety and tolerability profile throughout those studies.

SURPASS-IPF uses the same dosing schedule and active comparator evaluated in the earlier Phase 2b program, allowing researchers to build on the previous clinical evidence while studying a much larger patient population.

Investigators Welcome the Trial Design

Rafael Lupercio, MD, Pulmonologist at Shasta Critical Care Specialists in California and an investigator in the SURPASS-IPF study, said the trial design is particularly meaningful for people living with IPF.

He noted that every participant will receive active treatment instead of placebo, which is an important consideration in a disease that continues to worsen over time.

He believes the study has the potential to generate evidence that will be valuable for both physicians and patients when making future treatment decisions.

Patient-Focused Approach Remains a Priority

Celea Therapeutics says the trial was designed with patients in mind.

Instead of exposing participants to placebo treatment, the study directly compares deupirfenidone with an approved standard therapy.

This approach follows the patient-centered principles used during the company's earlier Phase 2b study, where unnecessary placebo exposure was kept to a minimum while still producing meaningful clinical data.

Medical Team Focuses on Real-World Treatment Decisions

Camilla Graham, Senior Vice President of Medical Affairs at Celea Therapeutics, said physicians often face difficult treatment decisions because current therapies offer limited efficacy and tolerability.

She explained that SURPASS-IPF is designed to answer one of the most important questions in clinical practice: whether deupirfenidone can provide meaningful improvement over today's standard treatment.

If successful, the study could help guide future treatment decisions and improve outcomes for people living with idiopathic pulmonary fibrosis.

Why New IPF Treatments Are Needed

Idiopathic pulmonary fibrosis is a rare, progressive lung disease that causes permanent scarring of lung tissue.

As the disease advances, lung function steadily declines, making it increasingly difficult for patients to breathe.

The median survival after diagnosis is generally between two and five years, and there is currently no cure.

Although approved antifibrotic therapies are available, many patients either do not start treatment or discontinue therapy because of limited effectiveness or tolerability concerns.

Celea believes deupirfenidone could help address these challenges by offering improved disease control while maintaining better tolerability.

About Deupirfenidone

Deupirfenidone, also known as LYT-100, is an investigational next-generation antifibrotic therapy and a deuterated form of pirfenidone.

The treatment has already received Orphan Drug Designation from both the US Food and Drug Administration and the European Commission.

Beyond idiopathic pulmonary fibrosis, the company is also exploring the therapy's potential in other fibrotic lung diseases, including progressive fibrosing interstitial lung diseases.

Phase 3 Results Expected in 2029

Celea Therapeutics expects topline results from the SURPASS-IPF study during the second half of 2029.

Based on previous discussions with the US Food and Drug Administration, the company believes data from this single Phase 3 study, together with results from the broader deupirfenidone development program, could support a future regulatory submission in the United States if the trial meets its objectives.

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