New IPF treatment moves ahead after encouraging study results
Early data suggest deupirfenidone may help slow lung function decline
Building on positive Phase 2 data, Puretech Health plans to launch a Phase 3 trial in the coming months to further test its experimental oral therapy deupirfenidone (LYT-100) in people with idiopathic pulmonary fibrosis (IPF).
“We are now advancing this pivotal program with urgency to bring forward a therapy with the potential to stabilize lung function and meaningfully improve care for people with IPF,” Sven Dethlefs, PhD, CEO of Celea Therapeutics, said in a company press release. Celea is a spinoff launched by Puretech to lead late-stage clinical development and potential commercialization of deupirfenidone.
The upcoming SURPASS-IPF trial will enroll adults with IPF who are not currently taking any IPF therapies. Participants will be randomly assigned to receive deupirfenidone or the approved IPF medication pirfenidone (sold as Esbriet, with generic formulations also available) three times daily for about a year. The trial’s main goal is to determine whether deupirfenidone is superior to Esbriet at slowing the decline in forced vital capacity (FVC), a key measure of lung function.
Phase 3 design builds on earlier ELEVATE-IPF study
The Phase 3 dosing and design build on an earlier Phase 2 study called ELEVATE IPF (NCT05321420). That trial enrolled more than 200 people with IPF and found that participants given deupirfenidone had slower FVC decline than those given either pirfenidone or a placebo. According to Puretech, the average rate of FVC decline seen for patients given deupirfenidone for one year (in an open-label extension) was similar to what is typically seen in healthy older adults.
“The forthcoming Phase 3 SURPASS-IPF trial builds on the strong foundation established by the Phase 2b ELEVATE IPF trial, which demonstrated deupirfenidone’s robust and durable treatment effect as a monotherapy and its potential to become a new standard of care,” Dethlefs said. “In shaping the Phase 3 design, we incorporated learnings from recent IPF trials and collaborated closely with patients and clinicians to reflect the latest thinking in the field.”
Puretech recently met with the U.S. Food and Drug Administration (FDA) to review the Phase 2 data and discuss plans for the next trial. Based on the agency’s feedback, Puretech said positive results from the Phase 3 study could complete the data package required to support potential registration of deupirfenidone via a streamlined 505(b)(2) pathway. The trial is expected to begin in the first half of 2026, the company said.
“Our discussion with the FDA was productive and provided helpful feedback on key elements of our Phase 3 program and the overall data expectations for registration,” Dethlefs said.
IPF is a condition marked by fibrosis, or scarring, in the lungs. Pirfenidone is an approved oral therapy that blocks molecular signaling pathways that drive fibrosis. Although pirfenidone has been proven to be effective at slowing lung function decline in IPF patients, it often causes side effects that have limited its use. Deupirfenidone is a modified form of pirfenidone designed to offer a more tolerable safety profile, which may allow the use of higher, more effective doses.
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