$180M financing supports head-to-head Phase 3 IPF drug trial

Celea Therapeutics received $180 million in financing to develop deupirfenidone (LYT-100), an investigational therapy that the company says has the potential to serve as a new standard of care for people with idiopathic pulmonary fibrosis (IPF).

The funding will support the planned launch of SURPASS-IPF (NCT07284602), a head-to-head Phase 3 clinical trial designed to assess the therapy against pirfenidone, an approved IPF treatment sold as Esbriet, in up to 1,100 adults with IPF, ages 40 and older. Celea expects to initiate the trial in the next few months.

Investors in the financing included RA Capital Management, Leaps by Bayer, and Celea’s founder, Puretech Health, along with an unnamed large U.S.-based healthcare fund and an unnamed sovereign wealth fund.

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Funding advances Phase 3 trial

“We are grateful for the support and confidence of this exceptional group of investors, whose commitment enables us to initiate the Phase 3 SURPASS-IPF trial and advance development of deupirfenidone with the speed and focus this community deserves,” Sven Dethlefs, PhD, Celea’s CEO, said in a company press release.

IPF is a rare and progressive disease in which lung tissue becomes permanently scarred, causing a steady decline in lung function over time. Median survival after diagnosis is estimated at two to five years.

Despite the availability of approved IPF therapies, existing antifibrotic drugs have faced a tradeoff between modest efficacy and tolerability, according to Celea, and about 25% of people with IPF in the U.S. had ever received treatment as of 2019.

While Esbriet can slow the progression of lung scarring, it has been associated with various side effects, including digestive upset. Deupirfenidone is a modified version of the active ingredient in Esbriet that alters how the body processes the drug. According to Celea, deupirfenidone is expected to offer a better safety profile, potentially allowing higher doses that may improve antifibrotic activity relative to current therapies.

“People living with IPF continue to face a devastating disease with limited treatment options, and we believe deupirfenidone has the potential to deliver meaningful improvements for patients,” Dethlefs said.

In February, deupirfenidone was granted orphan drug status by regulatory authorities in both the U.S. and the European Union. This designation offers extra financial incentives to encourage companies to develop treatments for rare diseases.

Earlier trial showed lung function benefit

In a previous Phase 2b clinical trial called ELEVATE IPF (NCT05321420), deupirfenidone, when tested alone against a placebo, slowed lung function decline in IPF patients for at least six months while maintaining a favorable safety profile with fewer gastrointestinal side effects. Early results from an extension study suggested that these benefits may continue for at least one year.

SURPASS-IPF will compare deupirfenidone against pirfenidone in patients who have been diagnosed with IPF for up to seven years. Eligible participants must have had no prior exposure to deupirfenidone or pirfenidone, and less than 12 months of prior exposure to Ofev (nintedanib), or any other approved antifibrotic therapy.

Trial participants will receive either deupirfenidone at 825 mg three times a day or pirfenidone at 801 mg three times a day. The trial’s main outcome will be the change in forced vital capacity, a measure of lung function, after one year, with the aim of demonstrating that deupirfenidone is superior to pirfenidone.

Celea also said that deupirfenidone may have potential in other fibrotic lung conditions beyond IPF, including progressive fibrosing interstitial lung diseases.

“We are delighted to support Celea as it enters this important next stage of development,” said Laura Stoppel, PhD, a partner at RA Capital Management. “The compelling results generated to date with deupirfenidone and the Company’s bold Phase 3 SURPASS-IPF trial represent a differentiated opportunity to meaningfully change the treatment landscape in IPF.”

In a separate press release, Puretech announced the launch of Celea, an independent company developing deupirfenidone, following the $180 million financing round. It retains a 35.4% ownership stake in Celea along with royalties and milestone payments tied to potential future sales of deupirfenidone.

Robert Lyne, Puretech’s CEO, said the financing marks “a transformative milestone for both PureTech and Celea,” adding that the involvement of the investor group provides “powerful third-party validation of the deupirfenidone program.”