Deupirfenidone phase 2b trial achievements

Senior Hispanic man testing breathing function

PureTech Health, Boston-based clinical-stage biotherapeutics company, has announced positive results from its phase 2b ELEVATE IPF clinical trial evaluating deupirfenidone (LYT-100) at two dose levels three times a day (TID) over 26 weeks in patients with idiopathic pulmonary fibrosis (IPF).

Lead investigator Toby Maher, MD, PhD, said the randomized, double-blind, active- and placebo-controlled, dose-ranging trial is the first to assess a new therapy (deupirfenidone) in direct comparison to an existing standard-of-care treatment (pirfenidone). Dr. Maher is a professor of medicine and director of Interstitial Lung Disease at Keck School of Medicine, University of Southern California, Los Angeles.

“Deupirfenidone 825 mg TID reduced lung function decline to near-physiologic levels over 26 weeks and had an effect size, compared with placebo, that was approximately 50% greater than that seen with pirfenidone,” said Dr. Maher. “Deupirfenidone has the potential to offer patients a highly effective and tolerable treatment option.”

The phase 2b trial had 187 participants that were randomized to receive deupirfenidone 825 mg, deupirfenidone 550 mg, pirfenidone 801 mg (the FDA-approved dose) or placebo three times a day for 26 weeks. The deupirfenidone doses were selected based on data from the phase 1 trial.

According to PureTech, the trial achieved its primary endpoint based on the prespecified Bayesian analysis, with a 98.5% posterior probability. Deupirfenidone was superior in slowing the rate of lung function decline in patients with IPF compared to the placebo, as measured by forced vital capacity (FVC) at 26 weeks. The trial also successfully demonstrated a dose-dependent response. 

“Our goal in developing deupirfenidone is to offer better outcomes to people living with IPF,” said Eric Elenko, PhD, president and co-founder of PureTech. “The adoption and adherence of currently approved antifibrotics has been limited by a tradeoff between efficacy and tolerability, specifically related to gastrointestinal adverse events. This prevents many patients from initiating treatment or maintaining optimal therapeutic doses and, in turn, achieving the best possible outcomes.”

More than 90% of trial participants opted to enroll in an ongoing open-label extension (OLE), further evaluating the two doses of deupirfenidone. Preliminary data support a durable treatment effect and a consistent tolerability profile with the 825 mg dose. 

Deupirfenidone is a deuterated form of pirfenidone, which is one of the two standard-of-care treatments approved to treat IPF, in addition to nintedanib. Deupirfenidone breaks down more slowly in the body than pirfenidone.

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