Poxel, a French biopharma company, has wrapped up patient enrollment for the phase 2 DESTINY-1 clinical trial, which is evaluating PXL065 for the treatment of NASH.

An announcement in this connection was made by the company in late September.

PXL065, which is a deuterium-stabilized R-stereoisomer of pioglitazone, will be evaluated for efficacy and safety in the mid-stage trial in 123 noncirrhotic biopsy-proven NASH patients.

David E. Moller — EVP and Chief Scientific Officer of Poxel said: “Pioglitazone – and other thiazolidinedione drugs – exert both genomic (PPARγ) and non-genomic actions. PXL065, the deuterium-stabilized single R-stereoisomer of pioglitazone, has been shown to selectively mediate non-genomic effects of pioglitazone that can ameliorate key components of NASH pathophysiology including steatosis, inflammation and fibrosis.

“This preclinical profile provides for potential benefits in NASH but with an improved side effect profile with respect to PPARγ – mediated body weight gain and edema.”

The French clinical stage biopharmaceutical company is engaged in developing treatments for chronic diseases with metabolic pathophysiology that include non-alcoholic steatohepatitis (NASH) and rare disorders.

The 36-week DESTINY-1 clinical trial will be held across multiple clinical sites in the US. The mid-stage trial will be a randomized, dose-ranging, double-blind, placebo-controlled, parallel group study.

The primary endpoint study of the DESTINY-1 clinical trial will measure the relative variation in the percentage of liver fat content based on magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF).

Furthermore, the effects of PXL065 on liver histology and other metabolic and non-metabolic biomarkers will also be assessed in the mid-stage NASH clinical trial.

Poxel expects to release the DESTINY-1 clinical trial results in Q3 2022.

  David E. Moller, DESTINY-1 clinical trial, liver cirrhosis, NASH, Pascale Fouqueray, Pioglitazone, Poxel, POXEL SA, PXL065, Stephen Harrison