Pieris Pharmaceuticals Inc (OTCMKTS:PIRS) a biotech company advancing its Anticalin® BioTherapeutics technologies, reported the close of enrollment of healthy people in a placebo-controlled, blinded Phase 1 clinical study for its PRS-080 program. It can be defined as a hepcidin antagonist to cure anemia. This trial was performed at a single location in Germany.
PRS-080 was a single does escalating, placebo-controlled, blinded study at a dose range varying from 0.08 to 16 mg/kg. The study had forty-eight total healthy subjects of which 36 were administered with PRS-080 and rest 12 was administered with placebo. In the trial, no dose-limiting toxicities were seen and a MTD was not reached. Pieris intends to present the forthcoming un-blinded results at a scientific conference in 2H2015. It also wants to commence a first-in-patient study by the end of 2015 in last stage renal disease patients across multiple locations in Europe.
The expert comments
Stephen Yoder, the President and CEO of Pieris Pharmaceuticals Inc (OTCMKTS:PIRS) said that they are delighted to have concluded enrollment of the main clinical study. It is the second Anticalin drug to be administered in humans. With drug supply accessible, the management looks forward to rapidly progress PRS-080 into patient trials.
PRS-080 can be defined as a fully proprietary Anticalin plan that sequesters hepcidin, usually stated as the master negative controller of iron metabolism. The therapy has a pharmacokinetic profile to eliminate hepcidin in line with intended turnover dynamics. The objective of PRS-080 is to optimally activate iron trapped in iron storage cells, mainly in anemic patients identified with functional iron deficiency. It is funded by the EC FP7 health plan grant and supported by the EUROCALIN consortium, headed by Pieris.