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Pieris begins Phase I trial of anemia drug compound PRS-080

Germany-based biotechnology firm Pieris has started a Phase I clinical trial of PRS-080, an anti-hepcidin Anticalin therapeutic protein designed to treat anemia.

The placebo-controlled, single ascending dose evaluation trial is conducted in Germany and patients from the first cohort have been dosed.

The trial, designed to evaluate the safety and tolerability of the compound, will enroll about 48 healthy volunteers, of whom 36 are expected to receive PRS-080.

Subjects will be monitored for the compound’s safety and tolerability, while the company intends to report Phase I data before the end of 2015.

Pieris CEO Stephen Yoder said: "Underpinned by a six million Euro grant from the European Commission, this Phase I clinical trial will bring PRS-080 one step closer to patients not adequately responding to current anemia therapy, while also providing more clinical validation for the Anticalin drug class.

"By addressing a biomarker-rich pathway such as iron mobilization, we plan to evaluate the potential of this intervention even in early clinical studies."

PRS-080 is a fully proprietary Anticalin program that sequesters hepcidin, typically regarded as the master negative regulator of iron metabolism.

The company is focused on advancing its Anticalin technology to create differentiated drugs that are safer and more effective than conventional approaches.