Phenex and Prof Kramer will jointly develop Phenex´ FXR agonist Px-102 into a therapy for Non-Alcoholic Steatohepatitis (NASH) and Metabolic Syndrome

Ludwigshafen, Germany, July 20th, 2011

Phenex Pharmaceuticals AG today announced the engagement of Prof. Dr. Dr. Werner Kramer, the former Head of Diabetes and Metabolic Diseases R&D at Sanofi Aventis, as a senior scientific advisor. At the end of last year, Prof. Kramer has left Sanofi Aventis after 25 years of very successful practice in drug discovery and development to devote himself to new scientific challenges. His long- and outstanding expertise in research and development of innovative drugs for the treatment of metabolic diseases is now available for Phenex´ drug development programs.

“Prof. Kramer´s experience is invaluable for us”, comments Dr. Claus Kremoser, CEO of Phenex, the newly established collaboration. “For more than 20 years he was very successful with innumerable patents and publications in the field of Metabolic and Lipid Disorders and he was instrumental in the development of four approved drugs on the market, including the blockbuster diabetes drug Lantus®. It is this rare combination of outstanding science together with clinical development expertise that he contributes and that is so important for us to design the right development strategy of our key drug candidate Px-102.”

Phenex will initiate the clinical development of Px-102 with the first-in-man Phase I study in healthy volunteers this summer still. After the Phase I Px 102 will be tested in Phase II studies for its applicability to improve liver functions and other symptoms in patients with Non-alcoholic Steatohepatitis (NASH). NASH is a syndrome of an inflamed and fibrotic liver in the context of Metabolic Syndrome and Type 2 Diabetes. Most recent studies quote a prevalence for NASH of 5- 10% of the entire population in developed countries which is still rising and there is currently no  causal therapy approved. The diagnosis of NASH increases the risk to get Hepatocellular Carcinoma (HCC or liver cancer) by 15-fold and the risk to become liver cirrhotic and to die from this condition is also substantially increased.

Prof. Kramer comments Phenex´ FXR clinical development project as follows: „In Metabolic Diseases such as Metabolic Syndrome and Diabetes there is an established imbalance in carbohydrate, lipid and general energy metabolism. The nuclear bile acid receptor FXR corrects many of these imbalances by counterregulating target genes which are involved in these pathways. It was shown in animal models of metabolic diseases that Px-102 could indeed correct many of the biochemical abnormalities which occur in Metabolic Syndrome and Diabetes. Moreover, Px-102 shows additional specific hepatoprotective properties which suggests that this compound may be useful to combat NASH which is at the crossroads of metabolic and liver diseases. Thus, we will tests its effects in such patients but with the idea in mind to later extend the applicability of Px102 towards more general patient populations with metabolic defects such as people with dyslipidemia, metabolic syndrome or Type 2 Diabetes.

A focussed biotech company such as Phenex is ideally suited to explore the therapeutic potential of such a new promising and innovative drug candidate. Because it is its main drug program Phenex provides enough dedication as well as intellectual flexibility to unlock the potential of this compound in NASH and related conditions together with leading clinicians. I am convinced that leading pharma companies will be highly interested in joining this development program once we have shown the beneficial effects of Px-102 in man.”

Contact

Waldhofer Str. 104
69123 Heidelberg
Germany
Phone: +49 6221 65282-0
Fax: +49 6221 65282-10
Dr. Claus Kremoser
Thomas Hoffmann
mailto: info@phenex-pharma.com

About Phenex Pharmaceuticals AG

Phenex is a privately held drug discovery and development company headquartered in Heidelberg. The biopharmaceutical company can now build on nineteen years of expertise in exploring and defining innovative, potent and selective new drug candidates from small molecules. Phenex´s R&D activities are centered around diseases of liver such as NASH and cancer.