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Poxel Announces Additional Positive Results for Imeglimin Phase 2b Study in Japan for the Treatment of Type 2 Diabetes


POXEL SA (Euronext – POXEL - FR0012432516), a biopharmaceutical company
focused on the development of innovative treatments for metabolic
disorders, including type 2 diabetes, announced today additional results
from the Imeglimin Phase 2b study conducted in Japan. In addition to the
highly statistically significant (p<0.0001) top-line results for the
primary and key secondary endpoint, the Company is reporting additional
data from this study. This press release is being issued in conjunction
with a corporate presentation at the Jefferies global healthcare
conference today at 4 pm ET. To access the webcast, please use the
following link

The Phase 2b randomized, double-blind, placebo-controlled study tested
three doses of Imeglimin (500 mg, 1000 mg and 1500 mg) administered
twice-daily for 24 weeks in 299 Japanese patients for the treatment of
type 2 diabetes. In this study, a statistically significant (p<0.0001)
decrease in the primary endpoint of HbA1c was observed along with
consistent, statistically significant (p<0.0001) decreases in the key
secondary endpoints of fasting plasma glucose, glycated albumin and
percentage of patients reaching a target HbA1c of less than 7%. A
statistically significant dose dependent (500 mg p=0.008,1000 mg
p=0.0008, and 1500 mg p<0.0001) improvement of the homeostasis model
assessment of beta-cell function (HOMA-B), a marker of beta cell
function in fasting condition, was also observed and is consistent with
previously published data. In addition, there was a significant decrease
in two of the most relevant liver enzymes, alanine aminotransferase
(ALT) and gamma-glutamyl transferase (GGT), which are considered
biomarkers in liver disease. The ALT and GGT results reflect an
improvement of liver function and are consistent with previously
published data in animal models. These data support Imeglimin's unique
dual mechanism of action of improving both insulin secretion and
sensitivity, which are the two key defects that cause type 2 diabetes.

In this study, Imeglimin was safe and well tolerated and the adverse
event profile was consistent to what was observed in the U.S. and EU
Phase 1 and 2 programs. No serious adverse events related to Imeglimin
were reported. There was no difference in the overall incidence of
patients presenting with at least one treatment emergent adverse event
between treatment and placebo groups. Of particular note, in this study,
the safety and efficacy of Imeglimin in patients with mild to moderate
chronic kidney disease was similar to patients with normal renal
function. Furthermore, no weight gain from Imeglimin was observed.

"Imeglimin's effect on beta cell function through HOMA-B is very
meaningful. We believe that Imeglimin could be particularly well-suited
for Japanese patients with type 2 diabetes and this effect may be an
important contributor to the robust efficacy seen in our Phase 2b study
in Japanese patients," said Pascale Fouqueray, MD, PhD, Executive Vice
President, Early Development & Translational Medicine of Poxel. "The
additional data demonstrating a decrease in liver enzymes are promising
and could represent an added benefit to type 2 diabetes patients who are
at a high risk for liver disease."

As previously reported, the primary endpoint of the trial achieved
statistical significance (p<0.0001) for the change from baseline in
HbA1c versus placebo in all treatment groups at 24 weeks. In the study,
placebo adjusted HbA1c reduction was 0.52%, 0.94% and 1.00% for the 500
mg, 1000 mg and 1500 mg dose twice-daily, respectively.

The Company anticipates meeting with the Pharmaceuticals and Medical
Devices Agency (PMDA) in Japan during the third quarter of this year,
and pending feedback from the meeting, the Company anticipates advancing
Imeglimin into a Phase 3 program in Japan during the fourth quarter of

"Japan is a key focus and an integral part of our business strategy,
especially with the unique treatment paradigm for innovative new
therapies. Given Imeglimin's novel mechanism of action coupled with the
results of this Phase 2b trial, we believe Imeglimin is a prime
candidate for first-line therapy either as monotherapy or as an add-on
to other glucose lowering therapies for the treatment of patients with
type 2 diabetes," said Thomas Kuhn, CEO of Poxel. "We look forward to
advancing Imeglimin into a Phase 3 program in Japan."

About Imeglimin

Imeglimin is the first clinical candidate in a new chemical class of
oral agents called the Glimins. Imeglimin has a unique mechanism of
action (MOA) that targets mitochondrial bioenergetics. Imeglimin acts on
the three main target organs involved in glucose homeostasis: the liver,
muscle, and the pancreas. This MOA has the potential for glucose
lowering benefits, as well as the potential to prevent endothelial
dysfunction, which can provide protective effects on micro- and
macro-vascular defects induced by diabetes. The additional protective
effect on beta-cell survival and function may lead to a delay in disease
progression. This unique mode of action compared to existing treatments
for type 2 diabetes makes Imeglimin a prime candidate in all stages of
the current anti-diabetic treatment paradigm, including monotherapy or
as an add-on to other glucose lowering therapies for the treatment of
patients with type 2 diabetes.

About Poxel SA

Poxel uses its development expertise in metabolism to advance a pipeline
of drug candidates focused on the treatment of metabolic disorders,
including type 2 diabetes. We have successfully completed a Phase 2
clinical program for our first-in-class lead product, Imeglimin, which
targets mitochondrial dysfunction, in the U.S., EU and Japan. Our second
program, PXL770, a direct AMPK activator, is in Phase 1 development. We
intend to generate further growth through strategic partnerships and
pipeline development. (Euronext: POXEL,

* Source: Oppenheimer & Co. estimates

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