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AB201 (rNAPc2)

Phase 2

Coronary Disease | Small molecule | Cardiovascular |Oruka Therapeutics, Inc.|Last Updated: Feb 21, 2023

Target and mechanism

Molecular targettissue factor
Target classProtein
ModalitySmall molecule

Also known as rNAPc2

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

AB201 (rNAPc2) · 2 trials · 2 indications

Phase 2 2
NCT04655586Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19Covid19
COMPLETED160 Analytics
NCT00116012Anticoagulation With rNAPc2 to Eliminate MACE/TIMI 32Coronary Disease
COMPLETED300 Analytics
PHASE2COMPLETED
Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19
Covid19Unlock trial analytics
PHASE2COMPLETED
Anticoagulation With rNAPc2 to Eliminate MACE/TIMI 32
Coronary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportional Change in D-dimer Level From Baseline to Day 8, or Day of Discharge if Prior to Day 8 (Phase 2b)
8 days

Proportional change is represented as percent change, and is defined as: 100 × (D-Dimer level at Day 8 or early discharge - D-Dimer level at baseline) / D-Dimer level at baseline. Baseline and post-baseline D-Dimer results are tested in the same laboratory, i.e. both from central laboratory, or local laboratory paired samples if the central laboratory values are not available.

Evaluation of the effects of a range of doses of rNAPc2 in subjects with non-STE acute coronary syndrome on safety and laboratory parameters from randomization until 7 days after the last dose of study drug

Secondary Endpoints

Proportional Change in D-dimer Level From Baseline to 24 Hours Post-dose (Day 2) and Day 3 (Phase 2b)
2 days and 3 days
Number of Major or Non-major Clinically Relevant Bleeding Events Within Eight (8) Days of Randomization as Compared to Heparin (Phase 2b)
8 days
Number of Major or Non-major Clinically Relevant Bleeding Events With rNAPc2 vs. Heparin Through Day 30 (Phase 2b)
30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
rNAPc2 Higher DoseEXPERIMENTALloading dose of 7.5 μg/kg SC on Day 1 followed by 5 μg/kg SC on Days 3 and 5
rNAPc2 Lower DoseEXPERIMENTALloading dose of 5 ug/kg SC on Day 1 followed by 3 ug/kg SC on Days 3 and 5
HeparinACTIVE_COMPARATORheparin at either prophylactic or therapeutic doses per Standard of Care at Institution

Interventions

NameTypeDescription
rNAPc2DRUGtwo dose levels of rNAPc2
HeparinDRUGstandard of care heparin per institution (therapeutic or prophylactic regimen)
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Eligibility Criteria

Age Range18 Years to 90 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: 1. Age ≥ 18 years and ≤ 90 years at the Screening assessment 2. Weight ≥ 50 kg at randomization 3. Hospitalized with a diagnosis of COVID-19 and in need of inpatient medical care 4. Positive for SARS-CoV-2 on nasopharyngeal, oropharyngeal or other tissue/body fluid samples by PC...

Countries:United StatesArgentinaBrazil
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Competitive Landscape -Coronary Artery Disease 99 trials (matched to "Coronary Disease")

Frequently asked questions about AB201 (rNAPc2)

What is AB201 (rNAPc2) used for?

AB201, also known as rNAPc2, is an investigational drug studied for coronary disease and COVID-19. It has been evaluated in Phase 2 clinical trials, including a study of anticoagulation in patients with coronary disease and a study assessing safety, hospitalization, and efficacy in COVID-19 patients.

What does AB201 (rNAPc2) target?

AB201 (rNAPc2) targets tissue factor, a protein involved in the coagulation cascade. By binding to tissue factor, the drug is designed to inhibit the coagulation process. This mechanism underlies its investigation as an anticoagulant in conditions such as coronary disease and COVID-19.

Who is developing AB201 (rNAPc2)?

AB201 (rNAPc2) is being developed by Oruka Therapeutics, Inc., which trades under the ticker ORKA. The company is responsible for the clinical development of this investigational asset.

What phase is AB201 (rNAPc2) in?

AB201 (rNAPc2) is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 trials have been completed, one in coronary disease and one in COVID-19.

What clinical trials is AB201 (rNAPc2) in?

AB201 (rNAPc2) has been studied in two completed Phase 2 trials. NCT04655586 evaluated safety, hospitalization, and efficacy in COVID-19 across the United States, Argentina, and Brazil. NCT00116012 assessed anticoagulation with rNAPc2 in coronary disease in the United States.

Is AB201 the same as rNAPc2?

Yes, AB201 is also known as rNAPc2. Both names refer to the same investigational drug developed by Oruka Therapeutics. The alternative name rNAPc2 is often used in scientific literature and clinical trial records.