Celea Therapeutics is speaking with regulators about launching a Phase III trial of its idiopathic pulmonary fibrosis (IPF) drug deupirfenidone after a Phase IIb open-label extension (OLE) success.
In the OLE phase of the ELEVATE IPF trial (NCT05321420), patients who were switched to deupirfenidone after receiving placebo or pirfenidone treatment in the randomised portion of the trial achieved stabilisation of lung function.
Established by PureTech to advance deupirfenidone, Celea Therapeutics believes that this data, delivered in a late-breaking oral presentation at the 2025 European Respiratory Society (ERS) Congress in Amsterdam, Netherlands, highlights the potential for deupirfenidone to become a new standard of care (SoC) for IPF.
In the OLE phase, patients who remained on deupirfenidone maintained a robust treatment effect, with an overall FVC decline of 32.8mL over 52 weeks. This is similar to the expected natural decline in lung function in healthy older adults over this period.
Those who switched from placebo had a mean improvement in FVC of 20.0mL while those who switched from pirfenidone had a mean reduction in FVC of 23.1mL.
ERS 2025 presenting investigator Dr Argyrios Tzouvelekis said: “Now we are seeing that two additional patient cohorts who experienced lung function decline in Part A of the trial achieved stabilisation once switched to deupirfenidone.
"These findings reinforce that the blinded results with deupirfenidone are reproducible and support the potential for benefit in patients transitioning from SoC.”
PureHealth announced in December 2024 that the randomised, double-blind, active-controlled and placebo-controlled ELEVATE IPF trial achieved its primary endpoint and demonstrated a statistically significant and clinically meaningful reduction in lung function decline at 26 weeks.
Patients achieved a 21.5mL reduction in lung function decline, as measured by change from baseline of Forced Vital Capacity (FVC), at 26 weeks compared to a 51.6mL decline in patients who received pirfenidone, and a 112.5mL decline in those who received placebo.
The most common treatment-emergent adverse events (TEAEs) in the OLE were nausea, dyspepsia, upper respiratory infections, and coughs.
Celea Therapeutics CEO Dr Sven Dethlefs said that the company is actively engaging with regulators to finalise the Phase III trial design, with an update expected in Q4 2025.
The SoC for IPF currently includes Ofev (nintedanib) and Esbriet (pirfenidone). These drugs have been approved based on their efficacy in slowing disease progression. There are challenges associated with use, including gastrointestinal issues and skin-related events that can affect patient adherence to the treatment regimen.
GlobalData analysts predict that deupirfenidone, a deuterated form of pirfenidone, could demonstrate superior outcomes compared to existing therapies, positioning the drug as a potential game-changer in the IPF treatment landscape.
GlobalData is the parent company of Clinical Trials Arena.
