Poxel Presents Results of Two Clinical Studies on its Direct AMP Kinase Activator, the PXL770, at the International Liver Con...
25 Giugno 2021 - 2:00PM
Business Wire
- Pr. Kenneth Cusi presented the results of the STAMP-NAFLD
12-week, randomized, controlled Phase 2a trial of PXL770 in 120
presumed NASH patients – selected as a “Best of ILC”
abstract
- Pr. Vlad Ratziu presented the results from a 4-week PK/PD
target engagement study of PXL770
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) presented the results of two studies at the
European Association for the Study of the Liver (EASL)
International Liver Congress™, held from June 23-26, 2021.
- On June 25, during an oral presentation [Abstract #427] in the
“NAFLD: therapy” session, Pr. Kenneth Cusi (U. of Florida)
presented the results of the 12-week, randomized, controlled Phase
2a trial in 120 presumed NASH patients, with or without T2DM, which
evaluated three dosing regimens of PXL770, Poxel’s lead direct AMP
kinase activator, versus placebo. The results showed that treatment
with PXL770 at 500 mg QD resulted in significant reductions in mean
liver fat content and alanine transaminase (ALT) levels (vs.
baseline). Greater effects were observed in patients with
coexisting Type 2 diabetes (T2D, 41-47% of each group): -27%
reduction in liver fat content at 500 mg QD vs. baseline; an
increase in the proportion of responders (>30% reduction in
liver fat); dose-responsive and significant mean decreases in ALT
and aspartate transaminase (AST) levels vs. placebo. In the T2D
patients, significant placebo-adjusted decreases were observed in
fasting plasma glucose and HbA1c (-0.64%) despite well-controlled
baseline fasting levels (121-144 mg/dL and 6.6-7.1%, respectively),
along with improvements in commonly used fasting indices of insulin
sensitivity (HOMA-IR and QUICKI scores). PXL770 was well tolerated
with an acceptable safety profile.
- On June 23, Pr. Vlad Ratziu (Université Pierre et. Marie Curie
and the Hôpital Pitié-Salpêtrière Medical School, Paris) presented
a poster [Abstract #159] with the results from a 4-week study
designed to assess the PK profile, safety, and target engagement of
PXL770 (500 mg QD) in 12 patients (plus 4 on placebo) with elevated
liver fat and insulin resistance. The observed PK profile and
safety results were consistent with previous results obtained in
Phase I studies with healthy subjects. PXL770 treatment produced a
significant suppression of de novo lipogenesis, indicating target
engagement, along with a significant improvement in glycemia (total
and incremental glucose AUC) following an oral glucose challenge
test (OGTT). Improvements in several indices of insulin sensitivity
were also observed.
“Taken together, the results of these two clinical studies
provide strong evidence of efficacy for PXL770 in patients with
non-alcoholic fatty liver disease, insulin resistance, and Type 2
diabetes,” commented Pascale Fouqueray, MD, PhD, Executive Vice
President, Clinical Development and Regulatory Affairs at Poxel.
“The results are also notable as they represent the first reported
clinical data for any direct AMP kinase activator in humans. Given
a favorable safety profile, along with evidence of metabolic
benefits with this lead molecule, we are also excited by the
prospect of pursuing this mechanism in other important clinical
indications in addition to NASH – potentially including
adrenoleukodystrophy.”
About Poxel SA
Poxel is a dynamic biopharmaceutical company that uses its
extensive expertise in developing innovative drugs for metabolic
diseases, with a focus on type 2 diabetes and non-alcoholic
steatohepatitis (NASH), and selected rare inherited disorders
including adrenoleukodystrophy. In its mid-to-late-stage pipeline,
the Company is currently advancing three drug candidates; several
earlier-stage opportunities are also underway. Imeglimin, Poxel’s
first-in-class lead product, targets mitochondrial dysfunction.
Poxel has a strategic partnership with Sumitomo Dainippon Pharma
for TWYMEEG® (Imeglimin) in Japan, China, South Korea, Taiwan and
nine other Southeast Asian countries. A new drug application for
TWYMEEG for the treatment of type 2 diabetes, was approved in
Japan. After successfully completing a Phase 2a proof-of-concept
trial for the treatment of NASH, which met its primary endpoint and
study objectives, for PXL770, a first-in-class direct adenosine
monophosphate-activated protein kinase (AMPK) activator, Poxel
plans to initiate a Phase 2b program in the second half of 2021.
PXL770 could also have the potential to treat additional metabolic
diseases. PXL065 (deuterium-stabilized R-pioglitazone), is in a
streamlined Phase 2 trial for the treatment of NASH. Poxel also has
additional earlier-stage programs from its AMPK activator and
deuterated thiazolidinediones (TZD) platforms targeting chronic and
rare metabolic diseases. The Company intends to generate further
growth through strategic partnerships and pipeline development.
Listed on Euronext Paris, Poxel is headquartered in Lyon, France,
and has subsidiaries in Boston, MA, and Tokyo, Japan.
For more information, please visit: www.poxelpharma.com
In the context of the COVID-19 outbreak, which was declared a
pandemic by the World Health Organization (WHO) on March 12, 2020,
the Company is regularly reviewing the impact of the outbreak on
its business.
As of the date of this press release, and based on publicly
available information, the Company has not identified the
occurrence of any material negative effect on its business due to
the COVID-19 pandemic that remains unresolved. However, the Company
anticipates that the COVID-19 pandemic could have further material
negative impact on its business operations. The worldwide impact of
COVID-19 may notably affect the Company’s internal organization and
efficiency, particularly in countries where it operates and where
confinement measures are implemented by the authorities. In
addition, COVID-19 may impact market conditions and the Company’s
ability to seek additional funding or enter into partnerships.
Particularly, delays in the supply of drug substance or drug
products, in the initiation or the timing of results of preclinical
and/or clinical trials, as well as delays linked to the
responsiveness of regulatory authorities could occur, which could
potentially have an impact on the Company’s development programs
and partnered programs. The Company will continue to actively
monitor the situation.
All statements other than statements of historical fact included
in this press release about future events are subject to (i) change
without notice and (ii) factors beyond the Company’s control. These
statements may include, without limitation, any statements preceded
by, followed by or including words such as “target,” “believe,”
“expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,”
“project,” “will,” “can have,” “likely,” “should,” “would,” “could”
and other words and terms of similar meaning or the negative
thereof. Forward-looking statements are subject to inherent risks
and uncertainties beyond the Company’s control that could cause the
Company’s actual results or performance to be materially different
from the expected results or performance expressed or implied by
such forward-looking statements.
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Poxel SA Elizabeth Woo Senior Vice President, Investor
Relations, Corporate Communications and Public Relations
Elizabeth.woo@poxelpharma.com
Catherine David Investor Relations & Communication Manager
catherine.david@poxelpharma.com +33 7 64 57 61 78
Investor relations / Media - EU/US Trophic Communications
Stephanie May or Valeria Fisher poxel@trophic.eu +49 171 185 56 82
or +49 175 804 1816
Investor relations / Media - France NewCap Emmanuel Huynh
or Arthur Rouillé poxel@newcap.eu +33 1 44 71 94 94
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