PureTech's Lung Disease Candidate Slowed Lung Function Decline In Idiopathic Pulmonary Fibrosis Patients

PureTech Health plc PRTC stock is up on Monday, after the company announced results from ELEVATE IPF Phase 2b trial of deupirfenidone (LYT-100) for idiopathic pulmonary fibrosis (IPF).

The trial evaluated deupirfenidone at two doses three times a day (TID) over 26 weeks in IPF patients.

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 trial achieved its primary endpoint based on the prespecified Bayesian analysis, with a 98.5% posterior probability, meaning that 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 (-21.5 mL vs. -112.5 mL, respectively; p=0.02)4 and represents a treatment effect of 80.9% as a monotherapy.
• pirfenidone 801 mg TID showed a treatment effect of 54.1% compared to placebo (-51.6 mL vs. -112.5 mL, respectively), consistent with previously reported pirfenidone clinical trial data.

The trial also achieved its key secondary endpoint showing a 99.6% probability that the pooled deupirfenidone arms were superior to the 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.

Deupirfenidone 825 mg TID also demonstrated a benefit on FVCpp endpoint compared to placebo that was statistically significant.

Both doses of deupirfenidone were generally well-tolerated in the trial. The overall number of patients experiencing any gastrointestinal (GI)-related adverse events (AEs) was similar across the deupirfenidone 825 mg TID and pirfenidone 801 mg TID arms.

Price Action: PRTC stock is up 10.10% at $22.40 at last check Monday.

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