Details of the SBP

General Information of Synthetic Binding Protein (SBP) (ID: SBP000058)
SBP Name
Anticalin PRS-080
Synonyms
PRS080; PRS 080#022-DP
Molecular Weight 21 kDa
Design Method Traditional methods (Site-directed mutagenesis and/or Directed evolution)
Expression System Escherichia coli BL21 (DE3)
Selection Method Phage display
Highest Status Phase II
Protein Scaffold Information of This SBP
Scaffold ID PS011
Scaffold Info
[1] , [2] , [3]
Scaffold Name Anticalin
Scaffold Class Non-Antibody
Fold Type One Alpha-Helix + Beta-Sheets + Loops
Binding Target(s) of This SBP (BTS)
BTS Name Details Mechanism Application Affinity Research Organization Ref
Hepcidin
BTS Info
Antagonist Anemia [ICD-11: 3A9Z]; Functional iron deficiency [ICD-11: 5B5K.0] Kd: 0.05 nM Pieris AG [1] , [2] , [3]
Clinical Trial Information of This SBP
EUCTR2016-004472-21-CZ Click to show the Detail
Indication Anemia
Phase Phase II
Title Phase IIa study to evaluate the safety, pharmacokinetics, and pharmacodynamics of repeated administrations over 4 weeks of the hepcidin antagonist PRS-080#022-DP in anemic chronic kidney disease patients undergoing hemodialysis
Status Not Recruiting
Sponsor Pieris Pharmaceuticals,GmbH
EUCTR2016-004472-21-DE Click to show the Detail
Indication Anemic Chronic Kidney Disease
Phase Phase II
Title Phase IIa study to evaluate the safety, pharmacokinetics, and pharmacodynamics of repeated administrations over 4 weeks of the hepcidin antagonist PRS-080#022-DP in anemic chronic kidney disease patients undergoing hemodialysis
Status Not Recruiting
Sponsor Pieris Pharmaceuticals GmbH
NCT02340572 Click to show the Detail
Indication Healthy
Phase Phase I
Title A First-in-Human, Randomized, Dose-Escalation, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Establish Safety, Lack of Immunogenicity, Tolerability, Pharmacokinetic Parameters, Target Engagement and Pharmacodynamic Effects
Status Completed
Sponsor Pieris Pharmaceuticals GmbH
NCT02754167 Click to show the Detail
Indication Anemic Chronic Kidney Disease
Phase Phase I; Phase II
Title Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Hepcidin Antagonist?PRS-080#022-DP in Anemic Chronic Kidney Disease Patients Undergoing Hemodialysis
Status Unknown
Sponsor Pieris Pharmaceuticals GmbH
NCT03325621 Click to show the Detail
Indication Anemic Chronic Kidney Disease
Phase Phase I; Phase II
Title Phase IIa Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Repeated Administrations Over 4 Weeks of the Hepcidin Antagonist?PRS-080#022-DP in Anemic Chronic Kidney Disease Patients Undergoing Hemodialysis
Status Completed
Sponsor Pieris Pharmaceuticals GmbH
References
1 In vitro-engineered non-antibody protein therapeutics. Protein Cell. 2018 Jan;9(1):3-14.
2 Recent advances in the development of novel protein scaffolds based therapeutics. Int J Biol Macromol. 2017 Sep;102:630-641.
3 Sustained plasma hepcidin suppression and iron elevation by Anticalin-derived hepcidin antagonist in cynomolgus monkey. Br J Pharmacol. 2018 Apr;175(7):1054-1065.