Using its hub-and-spoke business model, PureTech is launching a new company to develop deupirfenidone (LYT-100), its promising candidate for idiopathic pulmonary fibrosis (IPF) and other fibrotic and inflammatory lung conditions.
PureTech has established Celea Therapeutics with a “mission to transform the treatment of respiratory diseases,” the Boston-based company said in an Aug. 12 release.
Running the London-listed subsidiary is former Teva North America CEO Sven Dethlefs, Ph.D., who has orchestrated the development of deupirfenidone for PureTech for the last year-plus.
“I believe deupirfenidone has the potential to be a true turning point in the treatment of IPF,” Dethlefs said in the release. “Our phase 2b data demonstrated the potential for best-in-class efficacy with a favorable safety and tolerability profile—addressing two of the most critical limitations of current therapies.”
Among the reasons he was entrusted with the job was the role he played at Teva in the launch of another deuterated product, Austedo, a blockbuster drug for Huntington’s disease and tardive dyskinesia.
Deuteration is a process in which hydrogen atoms in a compound are replaced with a heavier isotope of hydrogen. It can improve the pharmacokinetic properties of existing drugs, increasing their efficacy and safety. Deupirfenidone is a deuterated version of Roche’s former IPF blockbuster Esbriet (pirfenidone), which became subject to generic competition in 2022.
Boehringer Ingelheim’s Ofev is the only other drug on the market for IPF. A year ago, the German company reported success in a phase 3 trial of its Ofev follow-on, nerandomilast. The PDE4B inhibitor is up for an FDA decision in the fourth quarter of this year.
PureTech says it hopes to meet with the FDA by the end of the third quarter to discuss the results of its phase 2b trial of deupirfenidone and its phase 3 trial plan.
Results from the 2b trial showed the potential of deupirfenidone to stabilize lung function decline over 26 weeks, while maintaining a favorable safety profile. Open-label extension data have indicated the effect continues for at least 52 weeks.
The launch of Celea is another example of PureTech’s approach, in which the company acquires promising assets and establishes subsidiaries to advance them individually. As an asset matures, it can draw new investments. With that comes an evolution of ownership, allowing PureTech to gain capital and the subsidiary to become more independent.
Using this model, 20-year-old PureTech, which is listed on the London Stock Exchange, has not had to raise money since 2018, CEO Bharatt Chowrira, Ph.D., explained to Fierce Pharma in an interview last year centered on the approval of Bristol Myers Squibb’s schizophrenia treatment, Cobenfy (KarXT).
PureTech spawned Karuna Therapeutics, which developed the treatment and was bought out by BMS in late 2023 for $14 billion.