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Poxel Announces Initiation of Part 2 of Phase 1a Study for PXL065, which is being Developed for the Treatment of NASH

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 that Part 2 of the Phase 1a study for PXL065, a
deuterium-stabilized R-stereoisomer of pioglitazone, has been initiated.
This second part of the Phase 1a study will enroll six healthy subjects
per group, with a primary objective to assess safety and tolerability
and a secondary objective to assess dose proportionality. This Phase 1a
trial, which was discussed with the U.S. Food and Drug Administration
(FDA) in a pre-Investigational New Drug Application (IND) meeting, was
designed to include two single oral doses and potentially up to three
additional doses of PXL065.


In Part 1 of the Phase 1a study, which was presented during the 2018
American Association for the Study of Liver Diseases (AASLD) meeting,
twelve healthy subjects received a single oral dose of 22.5 mg PXL065 or
45 mg ActosA®*. In this study, PXL065 was shown to be safe and
well-tolerated with no adverse events. Based on the pharmacokinetic (PK)
results, modeling predicts that a 15 mg dose of PXL065 may provide a
similar exposure of R-pioglitazone as a 45 mg dose of the parent drug,
pioglitazone (Actos), which suggests it should show similar efficacy
with an improved safety profile, including reduced weight gain and fluid
retention.


"Nonalcoholic fatty liver disease (NAFLD) is reaching epidemic
proportions worldwide and is the most common chronic liver condition in
obese patients with prediabetes or type 2 diabetes mellitus,a?? said
Kenneth Cusi, MD,A Chief of the Division of Endocrinology, Diabetes &
Metabolism in the Department of Medicine at the University of
Florida.A "Because the mechanism of action for PXL065 is known to target
mitochondrial pyruvate carrier (MPC) inhibition, PXL065 is expected to
have beneficial effects on insulin resistance and inflammation, which
are key components for treating steatohepatitis in patients with NASH.a??


"Shortly after signing the acquisition agreement with DeuteRx for
PXL065, the IND for PXL065 was transferred to Poxel, and we
subsequentially initiated Part 2 of the Phase 1a study. Data generated
from this latest study of PXL065, including the PK results and modeling
work based on the highest approved dose of pioglitazone, should enable
us to establish optimal doses for the next phase of development,a?? said
Thomas Kuhn, CEO of Poxel.
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