PureTech's Deupirfenidone Shows Positive Results In Slowing Lung Function Decline In IPF Patients

PureTech Health

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(RTTNews) - PureTech Health plc (PRTC, PRTC.L) announced positive results from the ELEVATE IPF trial. This Phase 2b, randomized, double-blind, active- and placebo-controlled, dose-ranging study evaluated deupirfenidone (LYT-100) at two dose levels, administered three times a day (TID) over 26 weeks in patients with idiopathic pulmonary fibrosis (IPF).

According to the company, Participants in the trial were randomized 1:1:1:1 to receive deupirfenidone 550 mg, deupirfenidone 825 mg, pirfenidone 801 mg (the FDA-approved dose), or placebo TID for 26 weeks, and had the option to enroll in an ongoing, open-label extension study. The two doses of deupirfenidone were chosen based on PureTech's Phase 1 data, which showed that a 550 mg TID dose of deupirfenidone provided approximately equivalent drug exposure to pirfenidone, 801 mg TID.

The trial achieved its primary endpoint based on the prespecified Bayesian analysis, with a 98.5% posterior probability. This means there is a 98.5% probability that the pooled deupirfenidone arms were superior to placebo in slowing the rate of lung function decline in people with IPF, as measured by forced vital capacity (FVC) at 26 weeks.

The trial also successfully demonstrated a dose-dependent response. The rate of FVC decline at week 26 with: deupirfenidone 825 mg TID compared to placebo was statistically significant and represents a robust treatment effect of 80.9% as a monotherapy; for context, the level of six-month natural decline in lung function as measured by FVC expected in healthy adults over 60 years old is approximately -15.0 mL to -25.0 mL.

The company noted that pirfenidone 801 mg TID showed a treatment effect of 54.1% compared to placebo, which is consistent with previously reported pirfenidone clinical trial data.

The trial also achieved its key secondary endpoint based on a prespecified Bayesian analysis, with a posterior probability of 99.6%. This means that there is a 99.6% probability that the pooled deupirfenidone arms were superior to placebo in slowing the rate of lung function decline in people with IPF, as measured by the forced vital capacity percent predicted (FVCpp) from baseline to week 26.

While FVCpp and FVC (the primary endpoint) are both measures of lung function, FVCpp accounts for key patient characteristics (age, sex, height, race) and therefore normalizes the results at the patient level. Deupirfenidone 825 mg TID also demonstrated a benefit on this endpoint compared to placebo that was statistically significant, reinforcing the robustness of the treatment's impact.

PureTech said it is committed to continuing development of deupirfenidone and intends to discuss the Phase 2b results with regulatory authorities to align on the appropriate path forward.