Policy & Regulation
POXEL starts phase 1b double-blind study of PXL065
19 September 2019 -

POXEL, a biopharmaceutical company, announced yesterday that it has started a phase 1b double-blind, randomised, placebo-controlled study in healthy patients to assess the safety, tolerability and pharmacokinetics and support dose selection of PXL065.

This study intends to confirm the predicted relative exposure and dose proportionality of PXL065. The product is the deuterium-stabilized R-stereoisomer of pioglitazone, aimed at mitochondrial pyruvate carrier inhibition. It is being developed for the treatment of noncirrhotic NASH patients and is hoped to offer an improved therapeutic profile over 45mg of pioglitazone.

The Phase 1b trial will evaluate the safety, tolerability and pharmacokinetics in around 30 healthy subjects, following seven days of receiving three doses (7.5mg, 15mg and 30mg) of PXL065 compared to 45mg pioglitazone. The study has opened sites and has started recruitment of patients. Topline results from this study are likely to be revealed in the fourth quarter of 2019.