4D) where PXL065 produced numerical improvements for each parameter. A post hoc analysis of pooled PXL065 treatment group results for individual parameters vs. The more stringent combined endpoint of NASH resolution with ≥1 stage improvement in fibrosis was numerically more frequent in each PXL065 treatment group (15-33%) vs. Potential improvements in NASH resolution response were noted ( Table 2). placebo were at a p=0.06 value in the 15 mg group. 17% with placebo ( Table 2) similar trends were observed with ≥1 stage fibrosis improvement without worsening of NASH ( Fig. 35-50% of PXL065-treated patients achieved ≥1 stage improvement in fibrosis vs.
4) and the percentage of patients achieving ≥2 point NAS reduction without worsening of fibrosis was greater with both 15 and 22.5 mg groups ( Fig. A dose-responsive and numerically greater proportion (43-58%) of PXL065 treated patients achieved a ≥2 point improvement in NAS (vs. placebo in several parameters were observed. NASH RESOLUTION WITH >1 POINT FIBROSIS IMPROVEMENTĪlthough not powered for histology endpoints, numerical improvements vs. NASH RESOLUTION WITH NO FIBROSIS WORSENING ≥2 POINT NAS IMPROVEMENT WITH NO FIBROSIS WORSENING ≥1 POINT FIBROSIS IMPROVEMENT WITH NO NASH WORSENING Cochran-Mantel-Haenszel test adjusting for stratification factors. ITT set Mixed Model for Repeated Measures (MMRM) with fixed effects for treatment, stratification factors, baseline endpoint specific parameter value, time point, and treatment by time point interaction.īiopsy completers (n=92 total placebo n=23 7.5 mg n=21 15 mg n=22 22.5 mg n=26).
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