Pliant Therapeutics $PLRX exploded more than 130% higher on July 11, 2022, because of lung disease trial results meeting key goals.
Pliant Therapeutics Announces Positive Safety and Efficacy Data from Phase 2a INTEGRIS-IPF Clinical Trial of PLN-74809 in Patients with Idiopathic Pulmonary Fibrosis
On July 10, 2022, Pliant Therapeutics 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.
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.
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.
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 mg treatment groups, respectively, versus 17.4% in the placebo group. A decline of ≥10% in percent predicted FVC (FVCpp) at 12 weeks is associated with an increased risk of death in IPF patients over a two-year period.1
An increase in QLF score is associated with an increase in pulmonary fibrosis. The mean percentage change in QLF at 12 weeks was 3.15%, 0.70% and 0.00% in the 40 mg, 80 mg and 160 mg treatment groups, respectively, versus 1.15% in the placebo group. These findings suggest a dose-dependent antifibrotic effect of PLN-74809, consistent with its mechanism of action and preclinical findings.
“Data from the INTEGRIS-IPF trial exceeded our expectations exhibiting a favorable safety and tolerability profile and a treatment effect on FVC, the current registrational endpoint in IPF. Importantly, the treatment effect was also observed on top of standard of care therapy,” said Éric Lefebvre, M.D., Chief Medical Offer at Pliant Therapeutics. “Additionally, the dose-dependent reduction observed in the proportion of patients experiencing a decline in percent predicted FVC of ≥10% underscores the potential of this novel investigational therapy to advance the treatment of IPF.”
“I am very encouraged by the Phase 2 results from INTEGRIS-IPF. IPF studies are challenging, as large samples sizes are usually required to detect a treatment effect,” said Lisa H. Lancaster, M.D., Professor of Medicine, Vanderbilt School of Medicine and INTEGRIS-IPF Principal Investigator. “The results from INTEGRIS-IPF are impressive, with PLN-74809 demonstrating a favorable safety profile and treatment effect both on and off standard of care therapy. The IPF patient community is in desperate need of new drugs given the limited treatment options currently available.”
📺 Pliant’s Approach: PLN-74809 – Pliant’s Tissue-Specific Approach to Treating Fibrosis
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