- The Phase 2 trial for the treatment of NASH met its primary efficacy endpoint; PXL065-treated patients achieved statistically significant improvements in the relative decrease in liver fat content measured by magnetic resonance imaging estimated proton density fat fraction (MRI-PDFF) at 36-weeks for all doses.
- Key secondary measures in PXL065-treated patients included a statistically significant improvement in Pro-C3, a biomarker of fibrogenesis.
- PXL065 was observed to be safe and well tolerated with no dose dependent increase in body weight and no increased lower extremity edema vs. placebo. Safety profile is consistent with reduced PPARg-mediated side effects vs. published results of pioglitazone.
- Histology results pending in September, along with the positive initial readout, will inform the next steps of PXL065 in NASH, including the potential for Phase 3 development.
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