Data from the Phase 2b ELEVATE IPF trial suggest deupirfenidone maintains efficacy while offering a favorable safety and tolerability profile.


RT’s Three Key Takeaways:

  1. Lung Function Stability: The Phase 2b ELEVATE IPF trial demonstrated that deupirfenidone has the potential to stabilize lung function decline in patients over a 26-week period.
  2. Safety and Tolerability: As a deuterated form of pirfenidone, deupirfenidone maintained a favorable safety profile that may address the tolerability issues that currently limit the use of antifibrotic therapies.
  3. Phase 3 Superiority Study: The upcoming Phase 3 SURPASS-IPF trial will evaluate deupirfenidone 825 mg against pirfenidone 801 mg in a head-to-head study designed to test for superiority.


PureTech Health announced the publication of results from the Phase 2b ELEVATE IPF trial of deupirfenidone (LYT-100) in The American Journal of Respiratory and Critical Care Medicine (AJRCCM). The study evaluated the investigational therapy for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease.

The trial results are informing the design of the upcoming Phase 3 SURPASS-IPF trial, which will evaluate deupirfenidone 825 mg three times a day monotherapy compared to pirfenidone 801 mg three times a day monotherapy. The Phase 3 study is powered to test for superiority and is expected to begin in the first half of 2026.

“The ELEVATE IPF trial provides a rare opportunity to evaluate an investigational therapy for IPF directly alongside a current standard-of-care treatment within a randomized controlled trial,” said Toby Maher, MD, PhD, professor of medicine and director of interstitial lung disease at Keck School of Medicine, University of Southern California, Los Angeles, in a news release.

Maher added that the magnitude of the treatment effect suggests it may be possible to achieve greater preservation of lung function than has historically been observed with currently available therapies.

The Phase 2b trial was a global, randomized, double-blind study involving 257 participants. Patients were randomized to receive either 550 mg of deupirfenidone, 825 mg of deupirfenidone, 801 mg of pirfenidone, or a placebo three times a day for 26 weeks. The primary endpoint focused on the rate of decline in Forced Vital Capacity (FVC), a standard measurement used to assess disease progression and predict mortality.

Deupirfenidone is a next-generation antifibrotic and a deuterated form of pirfenidone, which is one of three therapies approved by the Food and Drug Administration (FDA). PureTech noted that the uptake of approved antifibrotics has historically been limited by a tradeoff between efficacy and tolerability, and only about 25% of people with IPF in the US had received treatment as of 2019. The company is advancing the program with the goal of meeting standards set by the (FDA).

“Publication in AJRCCM validates the rigor of our Phase 2b trial design and execution and highlights the potential for deupirfenidone to set a new benchmark in the treatment of IPF,” said Sven Dethlefs, PhD, chief executive officer of Celea Therapeutics, in a news release.

Initial data from an ongoing open-label extension study suggest the stabilization of lung function decline may be sustained through at least 52 weeks.