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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.