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Poxel Presents Results for Imeglimin Phase 2b Study in Japan for the Treatment of Type 2 Diabetes at the European Association for the Study of Diabetes 53rd Annual Meeting

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  • Imeglimin Phase 2b trial in 299 Japanese patients achieved
    statistically significant results for its primary and secondary
    endpoints
  • Poxel recently completed the End of Phase 2 Meeting for Imeglimin
    with Japanese regulators and plans to initiate the Phase 3 program in
    the fourth quarter of 2017
  • The Japanese diabetes market is fast-growing and anticipated to
    reach approximately $6B by 2020
    *

POXEL SA (Euronext – POXEL - FR0012432516), a biopharmaceutical company
focused on the development of innovative therapies for metabolic
disorders, including type 2 diabetes, announced that results from the
Imeglimin Phase 2b study in Japan will be presented today in the Novel
Approaches to Glucose-Lowering Session in Poster 843 from 1:15-2:15 pm
in the Poster Hall at the European Association for the Study of Diabetes
(EASD) 53rd Annual Meeting. This scientific meeting is being
held from September 11-15th in the Parque das Nações, at the
International Fair of Lisbon in Portugal.

"The strong efficacy and favorable safety profile of Imeglimin observed
in this study suggests that it could be particularly well-suited for
Japanese patients," said Professor Kohjiro Ueki, MD, PhD, Director,
Diabetes Research Center, Research Institute, National Center for Global
Health and Medicine, Tokyo, Japan. "Diabetes is a growing health concern
in Asia and Imeglimin has the potential to become an innovative new
treatment option for Japanese patients to manage their type 2 diabetes."

"Japan is a key focus and an integral part of our business strategy. We
believe that Imeglimin's unique profile could be very attractive given
the specific needs of this important marketplace and the pathophysiology
of Japanese patients," said Thomas Kuhn, CEO of Poxel. "Due to
Imeglimin's safety and efficacy profile, it has the potential to be used
as first-line therapy for type 2 diabetes in Japan for treatment naïve
patients or in combination with other glucose lowering therapies, as
well as for the elderly and sensitive populations."

"We recently met with the Pharmaceuticals and Medical Devices Agency in
Japan for the Imeglimin End of Phase 2 Meeting to discuss our Phase 3
program. Based on the interactions with Japanese regulators and feedback
from this meeting, we plan to initiate the Phase 3 program for Imeglimin
in Japan during the fourth quarter of this year," continued Thomas Kuhn.

Imeglimin Results for the Phase 2b Study in
Japan

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, the
primary endpoint achieved statistical significance (p<0.0001) for the
change from baseline in glycated hemoglobin (HbA1c) versus placebo in
all treatment groups at 24 weeks. 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.

In this study, consistent, statistically significant (p<0.0001)
decreases at the top two doses in the key secondary endpoints of fasting
plasma glucose, glycated albumin and percentage of patients reaching a
target HbA1c of less than 7% were also achieved. 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. 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 are consistent with previously
published data in animal models.

"We are extremely pleased with the robust efficacy shown in this study.
We believe that Imeglimin's positive effect on beta cell function is
very meaningful and could be particularly important for Japanese
patients with type 2 diabetes," said Pascale Fouqueray, MD, PhD,
Executive Vice President, Early Development & Translational Medicine of
Poxel. "The additional data demonstrating an improvement 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."

Overall, the study showed that 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. In addition, no weight gain from Imeglimin was
observed.

The poster titled "Imeglimin monotherapy in Japanese patients with type
2 diabetes: results from a randomized, 24-week, double-blind,
placebo-controlled, phase IIb trial" is available on the Company's
website under "Scientific Publications" or by using the following link http://www.poxelpharma.com/en_us/product-pipeline/posters.

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 and diastolic 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, www.poxel.com)

* Source: Oppenheimer & Co. estimates

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