Colorado-based ARCA Biopharma (NASDAQ: ABIO) has announced that AB201 (rNAPc2) is under development as a potential therapy for the abnormal blood clotting associated with COVID-19. The company anticipates that an Investigation New Drug (IND) application will be filed in the third quarter of 2020 that the medication will be tested in humans during the second half of the year.
AB201 is an inhibitor of tissue factor (TF), a protein that initiates the primary blood clotting pathway in humans. The medication has been previously evaluated in phase 2 clinical trials in the context of other diseases, generating safety data which could support the “more rapid development” of AB201 as a therapy for COVID-19.
Scientific Director of the Center for Thrombosis and Hemostasis at the Johannes Gutenberg University Medical Center in Mainz, Germany, Dr. Wolfram Ruf, stated, “Our research, combined with the accumulating evidence on the clinical importance of large and small vessel thromboses in the COVID-19 infected patients, points to a potentially important role for the tissue factor pathway in viral infection, inflammatory response and the development of coagulopathy.”
“With its properties in modulating the TF pathway and the evidence from its prior development, rNAPc2 has the potential to be a uniquely beneficial therapy for patients with COVID-19,” Dr. Ruf continued.
Analysis of COVID-19 patients has revealed that, among other adverse events, aberrant blood clotting has the potential to occur, leading to ischemic stroke, pulmonary emboli, and heart attacks, among other conditions. Disordered blood clotting is also characteristic of infection by other highly lethal viruses including Ebola and Marburg virus.
AB201 would be evaluated in a phase 2B/3 clinical trial for “hospitalized COVID-19 patients with elevated D-dimer levels” with the Colorado Prevention Center, a clinical research center of the University of Colorado.
Director of the Colorado Prevention Center Dr. Marc Bonaca stated, “The thrombotic complications of COVID-19 are severe and stem directly from viral activity and vascular inflammation. By targeting tissue factor and the extrinsic pathway, AB201 may offer a unique approach that could simultaneously reduce the severity of the viral infection as well as reduce the risk of its thrombotic complications. The extensive Phase 2 safety experience in other diseases could enable more rapid development via a Phase 2B-Phase 3 adaptive program.”
President and CEO of ARCA Biopharma Dr. Michael Bristow stated, “During this global health crisis, we believe it is important to rapidly and collaboratively evaluate multiple technologies to address COVID-19 and the associated pathologic host responses.”
“The combination of anticoagulation, anti-inflammatory effects and antiviral activity have the potential to make AB201 a unique therapeutic to treat patients afflicted with COVID-19 while vaccine development is underway and for patients for whom a vaccine is not effective. We believe this therapeutic approach may also have potential to address future outbreaks of diseases related to other RNA viruses,” Dr. Bristow commented.
Other non-vaccine approaches to treating infection by the SARS-CoV-2 coronavirus are under evaluation, including Vir Biotechnology’s neutralizing antibody S309. The treatments by ARCA Biopharma and Vir Biotechnology are not intended to replace a vaccine but to support the societal battle against COVID-19 until a safe and effective vaccine becomes available.