On the back of the good scientific news, Phenex raises 5 Mio Euro in its fourth
(Series D) financing round

Ludwigshafen, Germany, October 31st, 2012

“We want to back Phenex´ in its ongoing R&D programs to achieve an optimum position in its planned partnering activities”
– Dr. Farsin Yadegardjam –
Head of Phenex´ Supervisory Board

Phenex Pharmaceuticals AG today announced the successful completion of its Phase I studies with Px-102, the company´s proprietary FXR agonist. Px-102 was tested in a single and in a multiple ascending dose Phase I study in 54 and 42 healthy volunteers, respectively. The drug candidate was safe and well tolerated at all doses indicated. Additional detailed data on the beneficial effects of Px-102 in animal models of lipid lowering and in preventing tumor growth in a liver cancer model were published by Phenex senior authors in the Journal of Experimental Therapeutics and Pharmacology (Hambruch et al, JPET, epub Aug 23, 2012) and in PLOSone (Deuschle et al. PLOSone 7(10) e43044, 2012).

The published data underscore that the massive cholesterol lowering effects of Px-102 observed in various animal models including primates, results in the prevention of atherosclerosis in a standard mouse model (JPET paper). The accumulation of free cholesterol in the liver is believed to be a main driving force for NASH (Non-Alcoholic Steatohepatitis, see “About Phenex”) thus cholesterol lowering will contribute to the overall hepatoprotective effects of Px-102. Given that Px-102 will be developed as a novel treatment for NAFLD and NASH, it was also important to investigate if the lipid lowering and other hepatoprotective effects observed so far might also be useful in the prevention of liver cancer. In the PLOSone paper the Phenex
authors show that multiple weeks of treatment with Px-102 inhibit tumor growth in a xenograft liver cancer model, probably via activation of a tumor suppressor gene, NDRG-2, which was identified as a novel target gene of FXR. The fact that Px-102 also effectively inhibits growth of liver tumors is relevant in a clinical setting where currently up to 5% of all NASH patients develop liver cancer over time so that the prevention of liver cancer is a main clinical goal in the treatment of NASH. The outcome of the Phase I human studies combined with the published data from animal models provide encouraging evidence that the FXR agonist Px-102 will show beneficial effects in patients with NASH, a metabolically induced chronic inflammatory and fibrotic  disease of the liver. These data together with the progress in Phenex´ second R&D program which targets RORgamma-t prompted Phenex existing investors to invest another 5 M Euro into Phenex. The additional funds will be earmarked for the further development of Px-102 and to broaden the ongoing RORgamma-t program.

“We want to back Phenex´ in its ongoing R&D programs to achieve an optimum position in its planned partnering activities”, explains Dr. Farsin Yadegardjam, Head of Phenex´ Supervisory Board and Managing Partner at EVP Capital Partners who manages the VRP fund which has financed Phenex from its first round on. “Phenex has successfully demonstrated its capabilities in preclinical research and early clinical development and we understand that more money helps creating more comprehensive data which furthers strengthens Phenex´ basis for negotiations in its outlicensing and partnering activities.”

Dr. Claus Kremoser, CEO of Phenex complements: “We are very pleased with these data since they demonstrated that our FXR agonist Px-102 has an enormous potential in gastrointestinal diseases beyond NASH, potentially even in the chemoprevention of liver cancer. And we are even more pleased that these good results strengthened the confidence of our investors into us so that we can further invest into both of our programs. Our RORgt inhibitor program which aims in developing a novel orally available drug for the treatment of autoimmune and chronic inflammatory diseases received great attention after the release of clinical study results with IL-17/IL17-R antibodies that showed the relevance of the RORgt/IL17 pathway in patients with psoriasis. Thus, it deserves enhanced efforts to remain at the forefront of RORgt research and our investors have enabled us to do this by investing another 5 M Euro into us. We are very grateful for this commitment.”

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.