Poxel has initiated the second part of the Phase Ia study of PXL065, which is being developed for the treatment of non-alcoholic steatohepatitis (NASH).
This part of the study will enrol six healthy subjects per group, with a primary objective to evaluate the safety and tolerability and a secondary objective to assess dose proportionality.
It will include two single oral doses and potentially up to three additional doses of PXL065.
The first part of the Phase Ia study saw 12 healthy subjects receive a single oral dose of 22.5mg of the drug candidate or 45mg actos.
Results showed the drug to be safe and well-tolerated, no adverse events reported.
Poxel CEO Thomas Kuhn said: “Shortly after signing the acquisition agreement with DeuteRx for PXL065, the IND for PXL065 was transferred to Poxel, and we subsequentially initiated part two of the Phase Ia study.
“Data generated from this latest study of PXL065, including the PK results and modelling work based on the highest approved dose of pioglitazone, should enable us to establish optimal doses for the next phase of development.”
PXL065 is a novel patent-protected drug candidate and offers a new approach for the treatment of NASH.
It also has the potential to preserve the pharmacological benefits of pioglitazone required for NASH treatment, a metabolic disease with no clear disease origin.
Kuhn added: “We believe that addressing a variety of relevant pathways, such as mitochondrial pyruvate carrier (MPC) inhibition with PXL065 and direct adenosine monophosphate-activated protein kinase (AMPK) activation with PXL770, could yield greater success in the treatment of NASH.”