POXEL SA announced the completion of enrollment in DESTINY-1 (Deuterium-stabilized R-pioglitazone (PXL065) Efficacy and Safety Trial In NASH), a dose-ranging Phase 2 trial evaluating PXL065 for the treatment of NASH. PXL065 is a novel, proprietary deuterium-stabilized R-stereoisomer of pioglitazone. DESTINY-1 enrolled 123 noncirrhotic biopsy-proven NASH patients across multiple clinical sites in the US in a 36-week, randomized, dose-ranging, double-blind, placebo-controlled, parallel group study designed to assess the efficacy and safety of PXL065. The primary endpoint of the study will measure the relative change in the percentage of liver fat content based on magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF). The study will also assess the effects of PXL065 on liver histology and other metabolic and non-metabolic biomarkers. Results from the Phase 2 study are anticipated in Third Quarter 2022. PXL065 DESTINY-1 Trial Design: The single Phase 2 36-week trial in 123 noncirrhotic biopsy-proven NASH patients will assess three doses of PXL065 (7.5, 15, 22.5 mg) compared to placebo. The primary endpoint of this trial will be the relative change in the percentage of liver fat content measured by MRI-PDFF at 36 weeks. The Phase 2 trial will also evaluate the efficacy on histological endpoints assessed by liver biopsy, assessment of other non-invasive tests and assessment of body weight changes. The goal of this trial is to identify the optimal dose or doses of PXL065 to advance into a Phase 3 registration trial for the treatment of noncirrhotic biopsy-proven NASH patients.