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PLN-74809 demonstrated a dose-dependent treatment effect on FVC and QLF versus placebo over 12 weeks of treatment
PLN-74809 treatment effect was observed on top of standard of care therapy and as monotherapy
PLN-74809 was well tolerated over 12 weeks of treatment with no drug related SAEs and no treatment discontinuations due to adverse events
Company to host webcast and conference call tomorrow, Monday July 11 at 8:00 am ET
SOUTH SAN FRANCISCO, Calif., July 10, 2022 (GLOBE NEWSWIRE) — Pliant Therapeutics, Inc. (NASDAQ:PLRX), today announced positive data from INTEGRIS-IPF, a multinational, randomized, double-blind, placebo-controlled Phase 2a clinical trial of PLN-74809 in patients with idiopathic pulmonary fibrosis (IPF). The trial met its primary and secondary endpoints demonstrating that PLN-74809 was well tolerated over a 12-week treatment period and displayed a favorable pharmacokinetic profile. The trial’s exploratory efficacy endpoints assessing changes in forced vital capacity (FVC) and Quantitative Lung Fibrosis (QLF) imaging, demonstrated a dose-dependent treatment effect on FVC and QLF versus placebo over 12 weeks in PLN-74809 treated patients.
INTEGRIS-IPF is a randomized, double-blind, placebo-controlled Phase 2a multinational study evaluating PLN-74809 at once-daily doses of 40 mg, 80 mg, 160 mg or placebo for 12 weeks in 90 patients with IPF. 67 patients were enrolled in the active arms and 23 patients were enrolled in the placebo arm. Approximately 80% of enrolled patients were on standard of care and were equally distributed between nintedanib and pirfenidone.
PLN-74809 Was Well Tolerated Across All Doses
The primary endpoint of the INTEGRIS-IPF trial is the evaluation of the safety and tolerability of PLN-74809. The secondary endpoint is an assessment of its pharmacokinetics.
PLN-74809 was well tolerated at all three doses tested. Of the 67 patients treated with PLN-74809, 65 (97%) completed 12 weeks of treatment with no discontinuations due to adverse events. No deaths or drug-related serious adverse events ( SAE) were reported. Most treatment emergent adverse events (TEAEs) were mild or moderate in severity.
PLN-74809 exhibited dose-proportional increases in plasma concentrations, consistent with prior studies.
PLN-74809 Demonstrated Dose-Dependent Treatment Effects on FVC and QLF Versus Placebo over 12 Weeks
The exploratory endpoints of the INTEGRIS-IPF trial measured changes in forced vital capacity (FVC), high-resolution CT (HRCT)-based QLF, and serum biomarkers over 12 weeks of treatment.
Figure 1. Change in FVC Over 12 Weeks in INTEGRIS-IPF; Mixed Model Repeat Measures Analysis – Intent to Treat Population
A treatment effect was observed in all PLN-74809 dose groups, with and without standard of care therapy. A pooled analysis of PLN-74809 treated patients showed an 80% reduction in FVC decline at 12 weeks versus placebo (-15.1 mL for PLN- 74809 pooled groups versus -74.1 mL for placebo). The 40 mg and 160 mg dose groups demonstrated 38% (-46.1 mL) and 66% (-25.1 mL) reductions in FVC decline relative to placebo, respectively. Importantly, in the 80 mg treatment group, a +24.6 mL increase in FVC was observed relative to baseline.
Figure 2. Proportion of Participants with FVCpp Decline ≥10% – Intent to Treat Population
A dose-dependent reduction in the proportion of patients with FVCpp decline of ≥10% was observed across treatment groups: 18.2%, 8.7% and 4.5% of patients experienced a ≥10% decline in FVCpp in the 40 mg, 80 mg and 160 …
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