DGAP-News: Poxel Raises EUR10 Million from New Investors to Progress Clinical Development of Two Novel Type 2 Diabetes Therapies

GERMANY


DGAP-News: Poxel S.A. / Key word(s): Financing
Poxel Raises EUR10 Million from New Investors to Progress Clinical
Development of Two Novel Type 2 Diabetes Therapies

09.09.2014 / 09:00

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Poxel Raises EUR10 Million from New Investors to Progress Clinical
Development of Two Novel Type 2 Diabetes Therapies

Lyon, France, September 9, 2014 - Poxel SA announces today, that it has
raised EUR10 million ($13.5 million) through a Series B extension with the
Large Venture investment division of Bpifrance (Banque Publique
d'Investissement) and a debt facility from Kreos Capital. The Series B
financing, originally led by Edmond de Rothschild Investment Partners
(EdRIP) now totals EUR18 million ($24 million). The funds will be used to 
accelerate the development of the company's lead program, Imeglimin, a
novel anti-diabetic agent and to move forward a direct AMPK activator
program which has proven benefits in controlling hyperglycemia and
dyslipidemia and is now ready for phase 1 clinical trials.

Imeglimin is the first in a new Tetrahydrotriazine-containing class of oral
anti-diabetics, the Glimins. Poxel has already demonstrated the efficacy
and safety of Imeglimin in clinical proof-of-concept trials and the product
is currently being developed through a phase IIb trial as a monotherapy in
400 patients. In addition, Imeglimin has previously shown significant
benefits as an add-on therapy to the main anti-diabetic agents, metformin
and sitagliptin.

Imeglimin has a mechanism of action that targets the mitochondria
bioenergetics. It is the first agent that acts directly on the two key
defects of Type 2 Diabetes, namely insulin sensitizing and secretion. This
unique mechanism of action, based on both preclinical and clinical study
results, has recently been detailed in three presentations, at the 74th
Sessions of the American Diabetes Association.

Thomas Kuhn, CEO of Poxel said: "We are glad to welcome the Large Venture
investment division of Bpifrance as new member to our investor syndicate
and Kreos Capital to support our activities. In addition to our ongoing
clinical studies, this financing will be used for initiating Imeglimin's
development in Asia. Moreover, it will ensure we have a sufficient
capital runway to progress our direct AMP Kinase program."

Mr. Raphaël Wisniewski, Partner at EdRIP, stated: "Poxel continues to
deliver on our expectations. With Imeglimin's phase 2b final results
expected in 2015, this further financing gives the company additional
resources to accelerate the development of its innovative programs and to
attract partners for the next development phase."

Mailys Ferrere, Head of the Large Venture investment division of Bpifrance,
said: "This investment into Poxel fits well with our mission to ensure the
continuum of business financing in which Bpifrance is invested, and in
particular that of the most innovative French biotech companies."

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 urbanization, 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 had 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 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. Imeglimin's
unique mechanism of action targets the mitochondria bioenergetics. This
distinct mode of action compared to existing treatments for Type 2 Diabetes
makes Imeglimin 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 are published in Diabetes Care.

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 2b clinical development and a
direct activator of AMPK, which is close to phase 1 development for the
treatment of Type 2 Diabetes.

For more information, please visit www.poxel.com

Media Contacts

Poxel SA                                   

Mrs. Pascale Malgouyres                     

Chief Business Officer                     

Phone: +33 437 372 012                     

Email: pascale.malgouyres@poxelpharma.com  


MC Services AG Munich

Mr. Raimund Gabriel 

Partner

Phone: +49 89 210 228 0

Email: raimund.gabriel@mc-services.eu



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