PRS-080: Best-in-Class Hepcidin Antagonist for Anemia

Candidate Targets Indication Partner Our Commercial
Rights
Discovery Preclinical IND-
enabling
Phase I Phase Ib/IIa
PRS-080 Hepcidin Anemia Major Markets Ex-Japan
Discovery Phase completed
Pre-Clinical Phase completed
IND-enabling Phase completed
Phase 1 completed
Phase 2 in progress

Pieris is addressing anemia through PRS-080, an Anticalin against hepcidin, which can restore iron utilization and erythropoiesis. This compound has successfully shown a favorable safety profile in healthy volunteers and is expected to complete a multi-dose trial in anemic patients with chronic kidney disease on hemodialysis in H2 2017.

PRS-080, an Anticalin against hepcidin, targets the large markets of anemia and functional iron deficiency (FID). During chronic inflammation, hepcidin levels in the body are elevated. Hepcidin traps iron in body stores and thereby leads to functional iron deficiency and impaired erythropoiesis. In turn, neutralization of hepcidin by PRS-080 restores iron utilization and erythropoiesis.

Pieris has completed a Phase I clinical trial with PRS-080 in healthy volunteers in 2015. In this trial, PRS-080 showed a favorable safety profile. The study also confirmed the mode of action of PRS-080. Within one hour of PRS-080 administration, a marked decrease in plasma hepcidin was seen, followed by elevations of both serum iron concentration and transferrin saturation. Moreover, the durations of serum iron elevation and transferrin saturation increased in a dose-dependent manner. Pieris has completed dosing in a Phase 1b trial in anemic patients with chronic kidney disease undergoing hemodialysis, and will conduct a multi-dose trial in the same patient population in H2 2017.

This program has been co-funded by the European Commission in the context of the FP7 health program (GA-No. 278408).

On February 27, 2017, Pieris entered into an option agreement for PRS-080 in Japan and other Asian countries with ASKA Pharmaceutical.