Poxel's Anti-diabetic Imeglimin Shows Significant Clinical Benefits in Type 2 Diabetes when Added to Sitagliptin
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Poxel's Anti-diabetic Imeglimin Shows Significant Clinical Benefits in Type 2
Diabetes when Added to Sitagliptin
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Phase II study achieved primary and secondary endpoints; Imeglimin brings
incremental efficacy on top of sitagliptin; and is safe and well tolerated
Lyon, France, 5 November 2012, - Poxel SA today announced that in a Phase II
study Imeglimin, a novel compound in development for Type 2 diabetes, showed
incremental efficacy as an add-on therapy to sitagliptin, in patients
inadequately controlled by sitagliptin monotherapy. The study achieved its
primary endpoint of superiority in HbA(1c) (blood sugar levels) reduction versus
placebo (p<0.001), and the decrease in FPG (Fasting Plasma Glucose) was also
statistically significant (p<0.006). Reduction in HbA(1c) and FPG are two
important measures of diabetes control.
Data from the Phase II trial assessed the clinical benefit of adding imeglimin
to sitagliptin in 150 patients. The trial demonstrated that in 12 weeks,
patients in the imeglimin-sitagliptin treatment group experienced 0.73%
reduction in HbA(1c) versus placebo. More patients responded to the imeglimin-
sitagliptin treatment than to the sitagliptin-placebo treatment (p<0.001). The
overall safety and tolerability profile in the imeglimin-sitagliptin group was
excellent.
Professor Valdis Pirags, Principal Investigator, commented: "I am pleased to see
this study meeting its end-points. Imeglimin is effective as add-on therapy to
sitagliptin with a great safety/tolerability profile. Combinability associated
to safety is essential for new products to tackle type 2 diabetes."
"The results from this add-on study are impressive. They do confirm the
attractiveness of Imeglimin for both regulators and future prescribers: the
molecule is unique and demonstrates its great efficacy potential in monotherapy
as in combination with the two most important molecules on the treatment
armamentarium today, metformin and sitagliptin", said Professor Harold Lebovitz,
a prominent member of Poxel's scientific advisory board.
Thomas Kuhn, CEO of Poxel added: "In just two years since our first round of
financing, the Company has now completed two successful phase II clinical trials
with Imeglimin. This second positive clinical trial demonstrates Imeglimin's
potential to complement the efficacy of major drugs, which brings further value
to our compound and added confidence in its further development. Within the type
2 diabetes landscape, Imeglimin is ahead in a race where new entrants have yet
to prove their efficacy, their combinability and their safety."
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 last year, 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). It was presented as a poster during the
73(rd) edition of the American Diabetes Association meeting in Philadelphia last
June and is already accepted for publication in Diabetes Care.
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 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 and now
operates independently as a lean organization with strong in-house drug
development 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 in pre-clinical development for the treatment of Type 2 diabetes.
For more information, please visit www.poxel.com
Media Contacts
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
Email: pascale.malgouyres(at)poxelpharma.com Email: raimund.gabriel(at)mc-
services.eu
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Source: Poxel S.A. via Thomson Reuters ONE
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