PureTech Health plc (PRTC, PRTC.L) has released favorable outcomes from its ELEVATE IPF study. This Phase 2b trial, which was randomized, double-blind, and involved both active and placebo-controlled groups, assessed the effects of deupirfenidone (LYT-100) at two different dosages, administered three times daily over a 26-week period, in individuals with idiopathic pulmonary fibrosis (IPF).
The study participants were divided equally into four groups: receiving either deupirfenidone at 550 mg or 825 mg, pirfenidone at the FDA-approved 801 mg dose, or a placebo, three times daily for the duration of 26 weeks. Participants also had the opportunity to join an ongoing open-label extension study. The dosages for deupirfenidone were selected based on PureTech's Phase 1 findings, which indicated that the 550 mg TID deupirfenidone dosage delivered approximately the same drug exposure as the 801 mg TID dose of pirfenidone.
The primary endpoint of the trial was successfully met, achieving a 98.5% posterior probability per the prespecified Bayesian analysis. This indicates a 98.5% likelihood that the combined deupirfenidone groups were more effective than placebo in reducing the rate of lung function deterioration, measured by forced vital capacity (FVC) at the 26-week mark.
Notably, the trial revealed a dose-dependent response. At week 26, the reduction in the rate of FVC decline with the 825 mg TID deupirfenidone, relative to placebo, was statistically substantial, demonstrating an 80.9% treatment effect as a single therapy. For context, a natural six-month decline in lung function in healthy adults over 60 years is typically between -15.0 mL and -25.0 mL.
It was also noted that the 801 mg TID pirfenidone dosage showed a 54.1% treatment effect compared to placebo, aligning with previously reported data from pirfenidone clinical studies.
Furthermore, the trial achieved its key secondary endpoint under a prespecified Bayesian analysis, with a posterior probability of 99.6%. This suggests a 99.6% probability that the combined deupirfenidone groups were superior to placebo in minimizing lung function decline, assessed by forced vital capacity percent predicted (FVCpp) from the baseline through week 26.
While both FVCpp and FVC (the primary endpoint) assess lung function, FVCpp adjusts for critical patient characteristics such as age, sex, height, and race, thus normalizing the results at an individual level. The 825 mg TID deupirfenidone also demonstrated a significant advantage on this measure compared to placebo, underlining the treatment’s effectiveness.
PureTech has expressed its commitment to further developing deupirfenidone and plans to engage with regulatory bodies to determine the next steps based on the Phase 2b findings.
The material has been provided by InstaForex Company -
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