Policy & Regulation
Poxel Shows Positive Histology Results from Phase 2 NASH Trial (DESTINY-1) for PXL065, a Novel, Proprietary Deuterium-Stabilized R-stereoisomer of Pioglitazone
23 September 2022 - - France-based clinical stage biopharmaceutical company Poxel SA (Euronext : POXEL - FR0012432516) has released positive histology results for DESTINY-1 (Deuterium-stabilized R-pioglitazone [PXL065] Efficacy and Safety Trial In NASH), the dose-ranging Phase 2 trial of PXL065 for the treatment of NASH, the company said.

PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone which has reduced PPARγ activity, but retains non-genomic thiazolidinedione actions.

DESTINY-1 is a Phase 2, 36-week, randomized, dose-ranging, double-blind, placebo-controlled, parallel group study designed to assess the efficacy and safety of PXL065 in patients with noncirrhotic biopsy-proven NASH across multiple clinical sites in the US.

The primary endpoint of the study measured the relative change in the percentage of liver fat content based on magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF).

The study also assessed the effects of PXL065 on liver histology and other metabolic and non-metabolic biomarkers.

117 subjects were randomized to one of 4 daily treatment arms (7.5 mg, 15 mg, 22.5 mg, placebo). Analysis of histologic changes was based on paired liver biopsies in PXL065 vs. placebo-treated NASH patients before and after the 36-week treatment period.

This trial was not powered to detect statistically significant changes in histology endpoints.
New top line results pertaining to liver histology and additional parameters included:
Biopsy Endpoints

Fibrosis improvement by >1 stage without worsening of NASH, an endpoint recognized by FDA for approval, occurred in 31-50% patients in the PXL065 study arms vs. 17% with placebo.

Across all PXL065 treatment arms (pooled data), 39% of patients had fibrosis improvement by ≥1 stage without worsening NASH (%) vs. 17% with placebo.
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