▎Editor of WuXi AppTec content team

Poxel has announced the positive histological top line results

NASH is a severe, progressive liver disease

▲PXL065 Introduction (Image source: Poxel official website)

PXL065 is an innovative, deuterium-stabilized pioglitazone

DESTINY-1 is a 36-week randomized, dose-range, double-blind, placebo-controlled, parallel-group Phase 2 clinical trial

Image source: Poxel official website

Previously published analysis of primary efficacy endpoints showed that the trial achieved the primary efficacy endpoint, with the mean percentage relative relative to hepatic fat loss (from baseline to 36 weeks) of 21-25% (p=0.

Image source: Poxel official website

It is worth mentioning that data analysis showed that PXL065 may have a benefit in glycemic control, and patients produced a decrease in glycosylated hemoglobin (HbA1c) levels associated with the dose of the drug (22.

Image source: Poxel official website

In addition, a slight increase in lipocamponectin levels up to +5.
26 ug/mL was observed in patients (22.
5 mg drug group vs.
placebo group, p<0.
0001), which showed that PXL065 caused only limited activation of PPARγ and may therefore reduce the occurrence
of adverse effects of weight gain and peripheral edema.

This is consistent with what has been observed in patients, with no cases of weight gain and edema associated with the dose of the
drug.

PXL065 is safe and well tolerated, with no treatment-related adverse effects
found in patients in the placebo and dose-as-dose groups.

Dr Thomas Kuhn, CEO of Poxel, said: "In addition to our previously announced clinically significant improvements in liver fat content and NASH cycle biomarkers in patients, this result addresses a highly unfinished need for fibrosis improvement in oral products, which is a turning point
in treatment.

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