Details of the SBP

General Information of Synthetic Binding Protein (SBP) (ID: SBP000420)
SBP Name
Kunitz domain Ecallantide
Synonyms
DX-88; Kalbitor; CB-500,929; EPI-KAL2
Molecular Weight 7.1 kDa
Design Method Traditional methods (Site-directed mutagenesis and/or Directed evolution)
Highest Status Marketed
Sequence Length 60
SBP Sequence
>Kunitz domain Ecallantide
EAMHSFCAFKADDGPCRAAHPRWFFNIFTRQCEEFIYGGCEGNQNRFESLEECKKMCTRD
Sequence Description Cys Iand Cys VI form disulfide bonds; Cys II and Cys IV form disulfide bonds; Cys III and CysV form disulfide bonds.
3D Structure
Computationally Modelled Structure
Click to Save PDB File
Protein Scaffold Information of This SBP
Scaffold ID PS043
Scaffold Info
[1] , [2]
Scaffold Name Kunitz domain
Scaffold Class Non-Antibody
Fold Type Alpha-Helices + Beta-Sheets + Loops
Binding Target(s) of This SBP (BTS)
BTS Name Details Mechanism Application Affinity Research Organization Ref
Plasma kallikrein
BTS Info
Inhibitor Hereditary angioedema [ICD-11: 4A00.14] Kd: 0.044 nM Dyax [1] , [2]
Clinical Trial Information of This SBP
EUCTR2005-003819-71-BE Click to show the Detail
Indication Hereditary Angioedema - EDEMA 3
Phase Phase III
Title EDEMA3: Evaluation of DX-88s Effects in Mitigating Angioedema A double-blind, placebo-controlled study followed by a repeat dosing phase to assess the efficacy and safety of DX-88 (recombinant plasma kallikrein inhibitor) for the treatment of acute attacks of Hereditary Angioedema-EDEMA 3
Status Not Recruiting
Sponsor Dyax Corp
EUCTR2005-003819-71-GB Click to show the Detail
Indication Hereditary Angioedema - EDEMA 3
Phase Phase III
Title EDEMA3: Evaluation of DX-88s Effects in Mitigating Angioedema A double-blind, placebo-controlled study followed by a repeat dosing phase to assess the efficacy and safety of DX-88 (recombinant plasma kallikrein inhibitor) for the treatment of acute attacks of Hereditary Angioedema-EDEMA 3
Status Not Recruiting
Sponsor Dyax Corp
EUCTR2005-003819-71-IT Click to show the Detail
Indication Hereditary Angioedema - EDEMA 3
Phase .
Title A double-blind, placebo-controlled study followed by a repeat dosing phase to assess the efficacy and safety of DX-88 recombinant plasma kallikrein inhibitor for the treatment of acute attacks of Hereditary Angioedema-Edema 3
Status Not Recruiting
Sponsor GENZYME
EUCTR2008-008354-23-DE Click to show the Detail
Indication Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
Phase Phase II
Title CONSERV TM C 2 (Clinical Outcomes and Safety Trial to Investigate Ecallantides Effect on Reducing Surgical Blood Loss Volume) C A Phase II Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding-CONSERV TM-2
Status Not Recruiting
Sponsor Cubist Pharmaceuticals
EUCTR2008-008354-23-PL Click to show the Detail
Indication Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
Phase Phase II
Title CONSERVTM C 2 (Clinical Outcomes and Safety Trial to Investigate Ecallantides Effect on Reducing Surgical Blood Loss Volume) C A Phase II Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding-CONSERV-2
Status Not Recruiting
Sponsor Cubist Pharmaceuticals,INC
NCT00262080 Click to show the Detail
Indication Hereditary Angioedema (HAE)
Phase Phase III
Title A Double-blind, Placebo-controlled Study (72 Patients, Randomized 1:1) Followed by a Repeat-dosing Phase to Assess the Efficacy and Safety of?DX-88?(Ecallantide; Recombinant Plasma Kallikrein Inhibitor) for the Treatment of Acute Attacks of Hereditary Angioedema
Status Completed
Sponsor Shire
NCT00448864 Click to show the Detail
Indication Blood Loss Associated With Heart Surgery
Phase Phase II
Title KALAHARI-1: Kallikrein Antagonist (DX-88?[Ecallantide]) Effect on Blood Loss Associated With Heart Surgery Requiring Institution of Bypass
Status Terminated
Sponsor Cubist Pharmaceuticals LLC
NCT00456508 Click to show the Detail
Indication Hereditary Angioedema (HAE)
Phase Phase III
Title Open-label Patient Continuation of?DX-88?(Ecallantide) for Acute Hereditary Angioedema Attacks
Status Completed
Sponsor Shire
NCT00457015 Click to show the Detail
Indication Hereditary Angioedema (HAE)
Phase Phase III
Title EDEMA4: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of?DX-88?(Ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema
Status Completed
Sponsor Shire
NCT00816023 Click to show the Detail
Indication Surgical Blood Loss Volume
Phase Phase II
Title CONSERV-1 (Clinical Outcomes and Safety Trial to Investigate Ecallantide's Effect on Reducing Surgical Blood Loss Volume) A Phase II Randomized Placebo-controlled Dose-ranging Study in Subjects Exposed to Cardio-pulmonary Bypass During Primary Coronary Artery Bypass Graft Surgery
Status Completed
Sponsor Cubist Pharmaceuticals LLC
NCT00888940 Click to show the Detail
Indication Surgical Blood Loss Volume
Phase Phase II
Title CONSERV-2 (Clinical Outcomes and Safety Trial to Investigate Ecallantide's Effect on Reducing Surgical Blood Loss Volume)-A Phase II Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding
Status Completed
Sponsor Cubist Pharmaceuticals LLC
NCT00969293 Click to show the Detail
Indication Macular Edema Associated; Central Retinal Vein Occlusion
Phase Phase I
Title An Open-label, Dose Escalating Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion
Status Terminated
Sponsor Fovea Pharmaceuticals SA
NCT01036659 Click to show the Detail
Indication Angioedema
Phase Phase II
Title Evaluation of?Ecallantide?for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Status Unknown
Sponsor Bernstein, Jonathan A., M.D.
NCT01059526 Click to show the Detail
Indication Hereditary Angioedema (HAE)
Phase Phase IV
Title A Phase IV, Long-Term Observational Safety Study to Evaluate Immunogenicity and Hypersensitivity With Exposure to?KALBITOR?(Ecallantide) for the Treatment of Acute Attacks of HAE
Status Completed
Sponsor Shire
NCT01253382 Click to show the Detail
Indication Hereditary Angioedema (HAE)
Phase Phase II; Phase III
Title A 3-Part Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Subcutaneous?Ecallantide?in Prepubertal Paediatric Patients Experiencing Acute Attacks of Hereditary Angioedema (HAE)
Status Withdrawn
Sponsor Shire
NCT01343823 Click to show the Detail
Indication ACE Inhibitor Induced Angioedema
Phase Phase II
Title Evaluation of?Ecallantide?for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Status Terminated
Sponsor Shire
NCT01826916 Click to show the Detail
Indication Hereditary Angioedema (HAE)
Phase Phase II
Title EDEMA2: An Open-Label Study to Assess the Efficacy and Tolerability of Repeated Doses of?DX-88?(Recombinant Plasma Kallikrein Inhibitor) in Patients With Hereditary Angioedema
Status Completed
Sponsor Shire
NCT01832896 Click to show the Detail
Indication Hereditary Angioedema
Phase Phase II
Title A Multicenter, Open-Label Study to Assess the Tolerability and Safety of a Single, Subcutaneous Administration of?Ecallantide?in Children and Adolescents With Hereditary Angioedema
Status Unknown
Sponsor Mark Davis-Lorton, MD
References
1 In vitro-engineered non-antibody protein therapeutics. Protein Cell. 2018 Jan;9(1):3-14.
2 KEGG DRUG Database. Ecallantide