Market Overview

Poxel Announces Positive Top Line 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 drugs to treat metabolic
diseases, including type 2 diabetes, announced today positive top line
Phase 2b data results for Imeglimin for the treatment of type 2 diabetes
in Japan.

The randomized, double-blind, placebo-controlled study of Imeglimin
administered twice-daily for 24 weeks,
demonstrated dose-dependent efficacy on two key measures of diabetes
control in 299 Japanese patients. The trial achieved statistical
significance (p<0.0001) for its primary endpoint of glycated hemoglobin
A1c reduction versus placebo in all treatment groups at 24 weeks. In the
study, hemoglobin A1c reduction was 0.52%, 0.94% and 1.00% for the 500
mg, 1000 mg and 1500 mg dose twice-daily, respectively. The level of
reduction of hemoglobin A1c for Imeglimin was even more pronounced in
the Japanese Phase 2b data than what has previously been shown in the
U.S. and EU Phase 2b data.

For the study's key secondary endpoint of a decrease in Fasting Plasma
Glucose (FPG), the top two Imeglimin doses of 1000 mg and 1500 mg
achieved statistical significance (p<0.0001) versus placebo at 24 weeks.
Analyses of data for the additional secondary endpoints are ongoing. In
this study, Imeglimin was shown to be 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.

The Company anticipates meeting with the Pharmaceuticals and Medical
Devices Agency in Japan during the third quarter, and pending feedback
from the meeting, the Company plans to be in the position to advance
Imeglimin into a Phase 3 program in Japan during the fourth quarter of

"The strong efficacy of Imeglimin observed in this study suggests that
its innovative mechanism of action may play an important role in the
treatment of type 2 diabetes and could be particularly well-suited for
Japanese patients," said Pascale Fouqueray, MD, PhD, Executive Vice
President, Early Development & Translational Medicine of Poxel.
"Imeglimin has been successfully studied in over 1,200 subjects and has
shown a differentiated product profile combined with favorable safety,
and we believe that it has the potential to address the large and
growing needs of the type 2 diabetes market."

"We are very pleased with these results and are actively preparing for
the Imeglimin Phase 3 program in Japan. The Phase 3 program is
anticipated to include 3 pivotal trials as well as non-pivotal studies
in specific patient populations to further differentiate Imeglimin from
other approved therapies in Japan," said Christophe Arbet-Engels, MD,
PhD, MBA, Chief Medical Officer and Executive Vice President, Late
Development & Medical Affairs of Poxel. "Diabetes is a growing health
concern in Asia and with these data results we are encouraged that
Imeglimin could become an innovative new treatment option for Japanese
patients to manage their type 2 diabetes."

"This is a significant milestone for Poxel. Japan is a key focus and is
an integral part of our business strategy, especially with the unique
treatment paradigm for innovative therapies. In Japan, we believe
Imeglimin may be a prime candidate for first-line treatment as
monotherapy and as an add-on to other glucose lowering therapies for the
treatment of patients with type 2 diabetes," said Thomas Kuhn, CEO of
Poxel. "Japan represents the second largest single market for type 2
diabetes and is expected to grow to approximately $6 billion in annual
sales in 2020*. Asia, in broader terms, is
considered the most important geographic location with regards to
treating the diabetes pandemic in the future."

Poxel anticipates presenting the full data results of the Phase 2b study
in Japanese patients at scientific meetings during the second half of

Poxel will host an investor conference call today to discuss the Phase
2b data results at 7 pm Central European Summer Time (1 pm Eastern
Daylight Time). To participate in the call, please use the dial-in
numbers below.

FR: +33(0)170770944
UK: +44 - 2033679459
US: +1 855-402-7764

Replay Number:
FR: +33(0)172001500
UK: +44 - 2033679460
+1 877-642-3018
REF: 308776#

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

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

View Comments and Join the Discussion!