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Poxel Initiates Phase 1b Multiple Ascending Dose (MAD) Trial for NASH Drug Candidate, PXL065



LYON, France--(BUSINESS WIRE)-- POXEL SA (Euronext: POXEL – FR0012432516), a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), today announced the initiation of a Phase 1b double-blind, randomized, placebo-controlled study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics (PK) as well as support dose selection for a pivotal study of PXL065. This study aims to confirm the predicted relative exposure and dose proportionality of PXL065.


PXL065, the deuterium-stabilized R-stereoisomer of pioglitazone, targets mitochondrial pyruvate carrier (MPC) inhibition. PXL065 is being developed for the treatment of noncirrhotic NASH patients and has the potential to provide an improved therapeutic profile over 45 mg of Actos®* (pioglitazone). Pioglitazone has been extensively studied in NASH with demonstrated efficacy 1,2, but its use is limited due to its side effect profile, including weight gain and fluid retention, which appear to be associated with the S-stereoisomer.



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