Poxel's Anti-diabetic Imeglimin Confirms Its Unique Mechanism of Action in Type 2 Diabetic Pati

Poxel's Anti-diabetic Imeglimin Confirms Its Unique Mechanism of Action in Type 2 Diabetic Patients

ID: 303184

(Thomson Reuters ONE) -
Poxel S.A. /
Poxel's Anti-diabetic Imeglimin Confirms Its Unique Mechanism of Action in Type
2 Diabetic Patients
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The issuer is solely responsible for the content of this announcement.

Imeglimin improves glucose-stimulated insulin secretion, confirming Imeglimin
potential to be combined to current diabetes treatments

Lyon, France, 7 October 2013, - Poxel SA, today announced that during a human
hyperglycemic clamp trial, Imeglimin, a novel compound in development to treat
Type 2 diabetes, increases insulin secretion in response to glucose, confirming
previous preclinical and clinical results. Imeglimin acts directly on the three
main organs affected by type 2 diabetes: the pancreas, the liver and the muscle.
This mechanism makes Imeglimin unique among the current anti-diabetic agents
available to physicians.

Poxel's objective was to confirm, in diabetic patients, Imeglimin's impact on
glucose-stimulated insulin secretion, using the reference method of
hyperglycemic clamp technique, including arginine stimulation to assess maximal
secretory capacity. This clinical pharmacology trial was a randomized, double-
blind, placebo-controlled, parallel-group study investigating insulin secretion
after Imeglimin chronic treatment. The trial included 30 patients; 15 per group.
 Results showed that Imeglimin met the primary and secondary endpoints, with a
statistically significant increase in the incremental area under the curve of
insulin response to glucose (iAUC(0-45min )insulin) and a  statistically
significant increase in the incremental area under the curve of C-peptide and
proinsulin response (iAUC(0-45min )C-peptide, iAUC(0-45min )proinsulin), in
comparison to placebo.





Professor Michael Roden, Poxel Scientific Board member, commented, "Imeglimin is
a very interesting novel agent, which, by improving glucose sensing of the
pancreatic beta cell, increases glucose-stimulated insulin secretion and this
contributes to the glucose lowering action of Imeglimin . Given the activity of
Imeglimin on both liver and muscle demonstrated in preclinical studies,
Imeglimin has a unique mechanism of action that could represent a new way of
addressing the pathophysiology underlying Type 2 diabetes".

Thomas Kuhn, CEO of Poxel added, "These positive data reinforce Imeglimin's
fully differentiated profile as a new anti-diabetic agent. No other single agent
impacts the three main organs involved in this chronic disease, which means
Imeglimin can be combined with any current diabetes treatments. This potential
was already evidenced in two clinical trials in combination with the two most
important molecules on the market today, metformin and sitagliptin. Combining
treatments to control glycaemia is now at the cornerstone of Type 2 diabetes
management".

The full study results will be submitted soon to a diabetes peer-reviewed
journal.

About Imeglimin

Imeglimin is the first in a new chemical class of oral anti-diabetic agents, the
glimins. Imeglimin acts on three main target organs involved in glucose
homeostasis: the liver, muscle, and the pancreas and has therefore a distinct
mode of action compared to existing treatments for Type 2 diabetes. In that, it
looks like the best partner to complement other treatments. Imeglimin phase 2a
monotherapy results were published in Diabetes, Obesity and Metabolism in April
2012.  In October 2011, Poxel reported phase 2 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). The study results are published in Diabetes
Care. In November 2012, Poxel reported phase 2 results of Imeglimin as add-on
therapy to sitagliptin in patients inadequately controlled with sitagliptin
monotherapy. This study achieved its primary end-point of superiority in HbA1c
reduction versus placebo (p<0.001). The study results, presented at ADA meeting
in Chicago this year, are under review by a diabetes peer-reviewed journal.

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
diseases.

The number of people with type 2 diabetes is rising rapidly worldwide. This rise
is associated with economic development, ageing populations, increasing
urbanisation, dietary changes, reduced physical activity and changes in other
lifestyle patterns.

 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 increase from $31 billion in
2012 to $48.8 billion in 2021 (source IMS audits).

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 novel treatments before seeking pharmaceutical industry partners. Poxel
was spun out from Merck Serono and now operates independently as a lean
organization with strong in-house drug development and business expertise.

Poxel's product pipeline consists of several first-in-class Type 2 diabetes
candidates, including Imeglimin in Phase II development. A direct activator of
AMPK is close to phase1 development for the treatment of Type 2 diabetes.

For more information, please visit www.poxel.com

Media Contacts


Poxel SA MC Services AG Munich

Mrs. Pascale Malgouyres Mr. Raimund Gabriel

Chief Business Officer Partner

Phone: +33 437 372 012 Phone: +49 89 2102 280

Email: pascale.malgouyres(at)poxelpharma.com Email: raimund.gabriel(at)mc-services.eu



Press release PDF:
http://hugin.info/143314/R/1733897/580647.pdf



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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
[HUG#1733897]




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Bereitgestellt von Benutzer: hugin
Datum: 07.10.2013 - 09:00 Uhr
Sprache: Deutsch
News-ID 303184
Anzahl Zeichen: 7977

contact information:
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