Date: 2017-06-04
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the 54th European Renal Association & European Dialysis and Transplant Association (ERA-EDTA) Congress
Company: Pieris (Germany)
Product: PRS-080
Action
mechanism: protein. Anticalins® are engineered human proteins that are able to bind specific target molecules. 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.
Disease: anemia
Therapeutic
area: Hematological diseases
Country: Germany
Trial
details: The Anticalin PRS-080#022-DP to be investigated in this study is directed against hepcidin and is intended for treatment of anemia of chronic disease. This phase I First-in-Human study shall investigate safety and pharmacokinetics in healthy human volunteers.(NCT02340572)
Latest
news:
- • On June 4, 2017, Pieris Pharmaceuticals announced the presentation of Phase 1b study results for its anemia program, PRS-080#022-DP, at the 54th European Renal Association & European Dialysis and Transplant Association (ERA-EDTA) Congress, convening in Madrid, Spain June 3-6, 2017. The poster presentation, entitled "A phase Ib study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of the hepcidin antagonist PRS-080#022-DP in anemic chronic kidney disease patients undergoing hemodialysis", was delivered by Dr. Lutz Renders, Professor at the Klinikum Rechts der Isar, Department of Nephrology, Munich, Germany, and the lead investigator on the clinical trial. The poster is available here. In this multi-center, placebo-controlled, double-blind study, 24 dialysis-dependent stage 5 chronic kidney disease (CKD5) patients with anemia were treated with single ascending doses of PRS-080#022-DP in 3 cohorts at 2, 4, and 8 mg/kg body weight.
- Intravenous administration of PRS-080#022-DP was both safe and well-tolerated at all doses, and resulted in a profound decrease in free hepcidin within one hour after infusion, followed by robust mobilization of serum iron, with dose-proportional increases in both the level and duration of serum iron concentration and transferrin saturation (TSAT) following treatment.
- • On December 7, 2015, Pieris Pharmaceuticals has presented detailed data summarizing the results from a Phase I clinical study in healthy male volunteers with its PRS-080 Anticalin hepcidin antagonist at the 57th Annual Meeting of the American Society of Hematology (ASH). The oral presentation entitled, "A Phase I Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of the Hepcidin Antagonist PRS-080#022. Results from a Randomized, Placebo Controlled, Double-Blind Study Following Single Administration to Healthy Subjects," outlined the favorable safety profile of the drug, as well as demonstrable proof of mechanism shown by increased serum iron levels as well as transferrin saturation in treated subjects.
- PRS-080 was well tolerated, with no serious adverse events (SAEs) observed in the single ascending dose (SAD) study at six dose levels administered by intravenous infusion in 48 healthy male subjects ranging from 0.08 to 16.0 mg/kg. Reported AEs were of mild to moderate severity with no apparent dose dependency or difference between active and placebo treatment groups. The plasma half-life of PRS-080 ranged between 71 and 81 hours among dose cohorts.
- Within one hour of PRS-080 administration, a marked decrease in plasma hepcidin was observed, followed by dose-dependent elevations of both serum iron concentration and transferrin saturation. Moreover, the durations of serum iron elevation and transferrin saturation also increased in a dose-dependent manner. Among all subjects receiving PRS-080 doses of 1.2 mg/ml and higher, statistically significant increases in total serum iron mobilization were observed relative to placebo (p = .005).
- • On June 10, 2015, Pieris Pharmaceuticals,a biotechnology company advancing its proprietary Anticalin® biotherapeutic technologies, announced 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.
- • On December 11, 2014, Pieris announced the initiation of a Phase I clinical trial with PRS-080, an anti-hepcidin Anticalin® therapeutic protein designed to treat anemia. The trial is a placebo-controlled, single ascending dose evaluation of the compound\'s safety and tolerability in healthy volunteers. Conducted in Germany, the trial is underway and patients from the first cohort have been dosed. The trial will enroll approximately 48 healthy volunteers, of whom 36 are expected to receive PRS-080. Subjects will be monitored for the compound\'s safety and tolerability. Pieris expects to report Phase I data before the end of 2015.
Is
general: Yes
