Pieris Pharmaceuticals Completes Dosing of Healthy Volunteers in Phase I Clinical Trial for Anticalin Program in Anemia

Pieris Pharmaceuticals, Inc. (OTCQB: PIRS), a biotechnology company advancing its proprietary Anticalin® biotherapeutic technologies, announced today the completion of enrollment of healthy subjects in a blinded, placebo-controlled Phase I clinical trial for the Company's PRS-080 program, a hepcidin antagonist to treat anemia. This study was conducted at a single site in Germany.

The study was a single dose escalating, blinded, placebo-controlled trial at a dose range from 0.08 to 16 mg/kg. The trial had 48 total subjects -- of which thirty-six were dosed with PRS-080 and twelve were dosed with placebo. In the study, no dose-limiting toxicities were observed and a maximum tolerated dose was not reached.

The Company plans to present the forthcoming unblinded data at a scientific conference in the second half of 2015. The Company also announced it intends to initiate a first-in-patient trial by the end of 2015 in end-stage renal disease patients across multiple sites in Europe.

"We are pleased to have completed enrollment of this clinical trial, which is the second Anticalin to be dosed in humans," commented Stephen Yoder, President and CEO. "With drug supply on hand, we look forward to rapidly advancing PRS-080 into patient studies."

PRS-080 is a fully proprietary Anticalin program that sequesters hepcidin, typically regarded as the master negative regulator of iron metabolism. With a pharmacokinetic profile tuned to remove hepcidin in line with target turnover dynamics, PRS-080 is intended to optimally mobilize iron trapped in iron storage cells, particularly in anemic patients characterized with functional iron deficiency. Funded by the EC FP7 health program grant GA-No. 278408, this program is supported by the EUROCALIN consortium, led by Pieris.