2013-03-07 10:05:08 -
Poxel S.A. /
First Patient In for Poxel's Imeglimin Phase IIb Monotherapy Trial to Treat Type
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
Lyon, France, March 7, 2013, - Poxel SA, today announced the initiation of a
phase IIb clinical trial of Imeglimin, a novel compound in development for Type
2 diabetes. The first patient was included in the trial which will span USA and
Europe. The trial will assess the dose-response of Imeglimin at four dose levels
compared to placebo in Type 2 diabetes patients after 24 weeks of treatment,
using the change in glycosylated hemoglobin (HbA1c) as the primary endpoint.
350 patients are expected to be tested in the multi-center, double-blind,
placebo-controlled, randomized study with five parallel groups, four Imeglimin
groups and one placebo group. Secondary endpoints of the trial include the
optimal dose and activity of Imeglimin compared to placebo on other glycemic and
non-glycemic parameters. Furthermore, this phase IIb trial will assess the
tolerability and safety of Imeglimin compared to placebo.
Thomas Kuhn, CEO of Poxel noted: "This is a very important milestone for
Imeglimin and Poxel; we have already proved Imeglimin as an excellent add-on
therapy to the standard treatments for Type 2 diabetes. With this trial
including over 350 patients, it is our intention to confirm Imeglimin's efficacy
in monotherapy, and complete our data package for partnering discussions."
The main patient inclusion criteria for the trial are: either men or women aged
between 18 and 75 years of age with Type 2 diabetes, who at the time of
screening are either not on anti-diabetic agents or treated with oral anti-
diabetic monotherapy, including metformin, sulfonylurea, dipeptidyl peptidase 4
(DPP- 4) inhibitors, glinide or acarbose. Some patients presenting with a mild
to moderate renal impairment will also be recruited in the trial.
Imeglimin represents a new treatment option for Type 2 diabetic patients, for
whom a significant unmet need remains. To date more than 400 subjects have been
treated in clinical trial settings, which proved Imeglimin effective, safe and
Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the
Glimins. Imeglimin has a mitochondrian-based mechanism of action, targeting the
respiratory chain. Through this new mechanism, Imeglimin acts on the three key
defects of Type 2 diabetes, inhibiting hepatic gluconeogenesis, increasing
muscle glucose uptake and restoring normal insulin secretion. Imeglimin phase
IIa monotherapy results were published in Diabetes, Obesity and Metabolism in
April 2012. In November 2012, Poxel reported phase II results of Imeglimin as an
add-on therapy to sitagliptin in patients inadequately controlled with
sitagliptin monotherapy. The study achieved its primary endpoint of reducing
HbA1c from baseline to week 12 vs. placebo plus sitagliptin. Specifically,
Imeglimin led to a significant reduction in HbA1c compared to placebo (p<0.001).
Imeglimin also met the secondary end- point of reducing fasting plasma glucose
(FPG) from baseline to week 12 vs. placebo (p<0.006). In October 2011, Poxel
reported phase II results of Imeglimin as add-on therapy to metformin in
patients inadequately controlled with metformin monotherapy. This study achieved
its primary end-point of superiority in HbA1c reduction versus placebo
(p<0.001). This trial was published online ahead of print in Diabetes Care.
Thanks to its mode of action and its great safety and tolerability profile,
Imeglimin appears as an excellent partner to complement current major anti-
About Type 2 Diabetes
Type 2 diabetes is the most common type of diabetes. It usually occurs in
adults, but is increasingly seen in children and adolescents. In Type 2
diabetes, the body is able to produce insulin but it is either not sufficient or
the body is not responding to its effects, leading to a build-up of glucose in
the blood. Type 2 diabetes is a major cause of both cardiovascular and kidney
The number of people with Type 2 diabetes is rising rapidly worldwide. This rise
is associated with economic development, ageing populations, increasing
urbanization, dietary changes, reduced physical activity and changes in other
The International Diabetes Federation estimates that in 2011, 366 million people
around the world have diabetes. This total is expected to rise to 552 million in
2030. Each year a further 7 million people develop diabetes. The current market
is dominated by few product classes and significant unmet needs remain for both
physicians and patients.
The worldwide pharmaceutical market for Type 2 diabetes, 60% of which is
represented by oral anti-diabetics, is expected to nearly double from $26
billion in 2011 to $48.8 billion in 2021.
About Poxel SA
Poxel, founded in 2009, is a biopharmaceutical company developing innovative
first-in-class drugs, with a primary focus on Type 2 diabetes. The company
develops drug candidates to clinical proof-of-concept before seeking
pharmaceutical industry partners. Poxel was spun out from Merck Serono. It
operates independently as a lean organization with strong in-house drug
Poxel's product pipeline consists of several first-in-class Type 2 diabetes
products, including Imeglimin in phase II development. Recently, Imeglimin has
also shown significant clinical benefits in Type 2 diabetes, when added to
sitagliptin. The Phase II study achieved the primary and secondary endpoints.
Previously, Imeglimin has shown incremental efficacy as an add-on therapy to
metformin, in patients inadequately controlled by monotherapy. In addition,
Poxel develops direct AMPK activator compounds with one being close to entering
phase I clinical trials for the treatment of Type 2 diabetes.
For more information, please visit www.poxel.com.
Poxel SA MC Services AG
Mrs. Pascale Malgouyres Mr. Raimund Gabriel
Business Development and Marketing Director Managing Partner
Phone: +33 437 372 012 Phone: +49 89 2102 280
Press release PDF:
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Poxel S.A. via Thomson Reuters ONE