Clinical Trial Results of PLN-74809 - PLN-74809 demonstrated dose-dependent target engagement and TGF-β suppression in prior studies[24] - PLN-74809 was well-tolerated over 12 weeks of treatment in the INTEGRIS-IPF trial[32] - PLN-74809-treated patients experienced an 80% reduction in FVC decline over 12 weeks (-15.1 mL, Pooled Active Groups) compared to Placebo (-74.1 mL)[33] - An improvement in FVC (+24.6 mL) was observed in PLN-74809 80 mg dose cohort[34] - A dose-dependent antifibrotic effect was seen on QLF Imaging, with no progression in the 160 mg group at Week 12[34] - PLN-74809 decreased serum biomarkers of collagen synthesis (PRO-C3 and PRO-C6) relative to placebo[34] Safety and Tolerability - Most Treatment Emergent Adverse Events (TEAEs) were mild or moderate in severity, and there were no discontinuations due to adverse events, deaths, or drug-related Serious Adverse Events (SAEs)[34] - The most frequent TEAE seen was diarrhea, but it was only observed in patients on standard of care[54] FVC Analysis - PLN-74809-treated participants experienced a benefit in FVC change from Baseline to Week 12 (-15.1 mL for pooled PLN-74809 group) compared to those on placebo (-74.1 mL)[77] - A dose-dependent reduction was observed in the proportion of participants with FVCpp decline of ≥10%[34] - Quantitative Lung Fibrosis (QLF) imaging showed a dose-dependent antifibrotic effect, with no progression in the 160 mg group at Week 12 based on mean change from baseline[84]
Pliant Therapeutics (PLRX) Earnings Call Presentation