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Pieris Announces Preclinical In Vitro and In Vivo Data for its Anticalin® PRS-080 Hepcidin Antagonist Drug Program

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Freising, Germany, May 23, 2011-- 

Pieris AG announced today preclinical in vitro and in vivo data for its PRS-080 Anticalin antagonist program targeting hepcidin, a small peptide which plays a pivotal role in the regulation of iron levels in the blood. PRS-080 showcases Anticalins’ ability to encapsulate small targets like hepcidin with high specificity and potency. The results of Pieris’ PRS-080 studies are being presented at the International BioIron Society Meeting being held May 22-26 in Vancouver, Canada in an oral presentation entitled "Exploiting lipocalin biochemistry for the treatment of anemia: discovery and characterization of an anti-hepcidin therapeutic".

"This program is extremely exciting because of the numerous lines of scientific evidence strongly suggesting the benefits of antagonizing hepcidin, a molecule that is aptly suited for targeting by Anticalins, for treating multiple forms of anemia," stated Laurent Audoly, Ph.D., Chief Scientific Officer of Pieris. "Because of the diverse clinical profiles of our target populations, we are also capitalizing on our ability to develop Anticalins with a range of half-life values in order to maximize the therapeutic index in any one disorder."

Pieris researchers documented that PRS-080 displayed sub-nanomolar potency, which translated into robust cell-based and in vivo efficacy. In a preclinical model of efficacy, PRS-080 administration showed complete inhibition of hepcidin-induced hypoferremia in a dose-dependent manner. The researchers also demonstrated a favorable half-life for the compound through further preclinical studies.

"Our hepcidin antagonist program highlights Pieris’ strategy of pursuing therapeutic programs with meaningful, clinically relevant differentiation over conventional molecules. Armed with these data and a healthy balance sheet, Pieris is committed to advancing PRS-080 as rapidly as possible toward the clinic," Stephen Yoder, Chief Executive Officer of Pieris, said. "We are aiming to achieve first-in-man readiness no later than the beginning of 2013, which girds this program with first-in-class potential."

Hepcidin is a liver-derived peptide that regulates iron homeostasis in the blood. Produced in response to iron overload and inflammation, hepcidin decreases iron absorption. When over-expressed, the peptide is associated with the development of anemia, often the result of chronic kidney disease, cancer, cancer treatments such as chemotherapy and other inflammatory diseases.

Pieris’ proprietary Anticalin technology platform creates next generation targeted therapeutics and addresses targets in ways that traditional methods cannot. To obtain a specific Anticalin, Pieris applies its deep protein engineering know-how to select drug candidates from its suite of rationally designed proprietary Anticalin libraries.

About Pieris

Pieris AG is an independent, clinical-staged biotechnology company advancing its proprietary AnticalinÒ technology to create safer, more efficacious and more convenient protein therapeutics. Exclusive to Pieris, Anticalin-based drugs promise to address high-unmet medical needs and expand the therapeutic potential of current targeted approaches. Pieris’ pipeline ranges from its Phase I compound, PRS-050 (anti-VEGF, oncology), to multiple Anticalins in preclinical development. The company has four ongoing discovery and development collaborations: Daiichi Sankyo, Takeda San Francisco, the Sanofi Group and Allergan. Privately held, Pieris has been funded by premier biotechnology-focused venture capital, including lead investors OrbiMed Advisors and Global Life Science Ventures. For more information, please visit:


For more information, please contact:

Stephen Yoder
Chief Executive Officer
Tel: +49 (0) 8161-1411-400


Gretchen Schweitzer
Tel: +49 172 861 8540