PureTech Health plc has announced the launch of Celea Therapeutics, a new standalone company focused on transforming treatment for serious respiratory diseases.
The stand-alone entity’s lead candidate is deupirfenidone (LYT-100), a Phase III-ready therapeutic candidate showing promise for idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Celea will be led by Sven Dethlefs, PhD, former CEO of Teva North America.
According to PureTech, creating Celea follows its proven model of spinning out focused entities, as seen with Karuna Therapeutics, to accelerate late-stage drug development in a capital-efficient way.
A meeting with the US Food and Drug Administration (FDA) is planned for the end of the third quarter (Q3) of 2025 to align on the registrational pathway and the start of Phase III trials.
Phase II Trial Results
The global Phase IIb ELEVATE IPF trial (NCT05321420) evaluated deupirfenidone at two doses, 550 mg and 825 mg, against Roche’s Esbriet (pirfenidone) 801 mg and placebo over 26 weeks in 257 patients with IPF.
The trial met its primary endpoint using a prespecified Bayesian analysis, showing a 98.5% probability that pooled deupirfenidone arms were superior to placebo in slowing forced vital capacity (FVC) decline. Results also indicated a dose-dependent benefit.
Dr. Dethlefs emphasized that the Phase IIb data point to “best-in-class efficacy” with a safety profile addressing the main drawbacks of current IPF therapies. “Deupirfenidone has the potential to be a true turning point in the treatment of IPF,” he said, noting the alignment of a strong clinical foundation, an experienced team, and a clear mission.
IPF landscape
Current care still relies on antifibrotics like Esbriet and Boehringer Ingelheim’s Ofev (nintedanib) to slow lung-function decline rather than reverse fibrosis. The current slate of pipeline drugs aims to add efficacy, tolerability, or disease-modifying effects.
Boehringer Ingelheim’s PDE4B inhibitor nerandomilast is the closest to market. The Phase III FIBRONEER-IPF and FIBRONEER-ILD trials both met their primary endpoint (FVC decline at 52 weeks), including on top of background antifibrotics. The US FDA recently granted priority review to the New Drug Application (NDA) for nerandomilast in IPF, with an anticipated action date in the fourth quarter of 2025.
In early development, Cereno Scientific’s CS014, a novel HDAC inhibitor, cleared Phase I with clean safety/tolerability and pharmacokinetics reaching exposures predicted to impact fibrosis biology, paving the way for a Phase II start in the first half of 2026.
