ARCA Biopharma Inc. (NASDAQ:ABIO) is developing a new program for evaluating AB201 (rNAPc2). It is a selective tissue factor inhibitor for treating coronavirus related coagulopathy (CAC) and associated inflammatory response.
ARCA to file IND application for AB201 in Q3
So far, coagulopathy is among the severe adverse effects witnessed in patients with COVID-19. The company has already subjected AB201 through a clinical test in a second phase involving over 700 patients showing other indications, and it generated significant safety data that ARCA Biopharma believes will enable rapid development of the drug.
The company is planning to file an Investigational New Drug application with the FDA in Q3 as well as initiate a late-stage clinical trial in the second half of 2020. The selective tissue factor is the protein that is responsible for the initiation of the extrinsic or primary coagulation pathway. Tissue factor is said to play a vital function in the inflammatory response to infections caused by viruses. In the patients in whom ARCA tested AB201, it demonstrated efficacy in inhibiting the tissue factor pathway, and its therapeutic doses were tolerated well.
AB201 is a possible COVID-19 therapy
Recent research indicates that the coronavirus-caused disease manifests as other coagulopathic disorders that affect blood’s ability to form clots. For instance, Ebola is exhibits signs of dysregulated activation of the tissue factor pathway, which results in abnormal coagulation and associated inflammation. According to studies, AB201 might have anti-inflammatory and antiviral activity plus the anticoagulant mechanism. As a result, this has led the company to strongly believe in investigating AB201 as a potential treatment for COIVID-19.
Michael Bristow, the CEO and President of ARCA, stated that it was important to evaluate various technologies in the pandemic to address the virus and related pathological responses in the host. He added that the combination of antiviral activity, anti-inflammatory effects as well as anticoagulation have a potential of making AB201 a possible therapy for COVID-19 patients as the process of vaccine development continues.