PureTech launches lung disease specialist Celea

PureTech Health has launched a subsidiary company – Celea Therapeutics – with the task of taking an experimental drug for idiopathic pulmonary fibrosis into late-stage clinical testing.

Celea has been formed to focus on the development of deupirfenidone (LYT-100), a deuterated form of Roche's well-established IPF therapy Esbriet (pirfenidone), which was a blockbuster product at its peak, with sales of $1 billion in 2021, but has now succumbed to generic competition.

According to PureTech, deupirfenidone could overcome limitations in the clinical profile of Esbriet, as well as Boehringer Ingelheim's rival IPF therapy Ofev (nintedanib), which remain the only two FDA-approved treatments for the disease.

Specifically, Esbriet and Ofev offer modest benefits in slowing lung function decline, largely due to tolerability challenges that limit the ability to achieve higher doses that could improve efficacy. In approximately 50% of cases, the dose of Esbriet is reduced to improve tolerability below the FDA-approved dose of 801 mg three times a day. Treatment is then discontinued, or patients switch to Ofev – or vice versa – to reduce the side effect burden.

Deuteration of a molecule involves replacing hydrogen atoms with deuterium, which can reduce side effects by creating a more stable drug molecule that is harder to break down, potentially leading to a longer half-life and reduced formation of toxic metabolites.

Deupirfenidone has already been shown to be less likely to cause gastrointestinal side effects than pirfenidone in a proof-of-concept trial, and last year PureTech reported phase 2b results that showed the drug was effective in slowing lung function decline in IPF patients at a level that the company said could represent a "step change" in treatment.

Despite limited efficacy, combined sales of Esbriet and Ofev reached a peak of around $5 billion, pointing to a big market opportunity for deupirfenidone if its profile is backed up in phase 3 and it reaches the market.

Ex-Teva exec Dethlefs named CEO

The move to phase 3, which should start in the coming weeks, will be overseen by former Teva North America head Sven Dethlefs, who has been named chief executive of Celea.

At Teva, Dethlefs oversaw a generic and branded medicines business worth $8 billion a year and oversaw the launches of key Teva products, including a deuterated product – dyskinesia and Huntington's disease treatment Austedo (deutetrabenazine) – which raked in nearly $1.7 billion in sales last year.

"I believe deupirfenidone has the potential to be a true turning point in the treatment of IPF," said Dethlefs. "The strength of the clinical data, combined with the team and mission behind Celea, makes this a uniquely compelling opportunity."

IPF is an incurable disease where the lungs become increasingly damaged by scar tissue, resulting in breathing getting progressively more difficult. To date, it has been considered a terminal illness.