ARCA Biopharma Inc. (NASDAQ:ABIO) has announced the submission of an Investigational New Drug Application to the FDA to evaluate AB201 in treating hospitalized COVID-19 patients under the Coronavirus Treatment Acceleration program.
ARCA to commence Phase 2b in Q4 2020
As the company waits for feedback from the FDA, it plans to commence Phase 2b part of its sequential Phase 2b/3 clinical trial for AB201 from the fourth quarter of 2020. The company’s CEO and President Michael Bristow stated that the IND application is a huge milestone for ATCA in the clinical evaluation of AB201. He added that they believe they have a robust scientific rationale, well-defined regulatory pathway, and safety data from previous human trials in more than 700, supporting AB201 as a potential COVID-19 treatment and other RNA virus-related diseases.
ARCA developed AB201 as a small recombinant protein that can be used as a possible treatment for several RNA virus-linked diseases with the initial focus being COVID-19. The treatment is a strong, selective inhibitor of tissue factor that plays an important role in the inflammatory response to viral infections and ion the viral dissemination process. The unique mechanism of action offers AB201 a combination of antiviral, immune-modulation, and anti-coagulant properties, making it potentially effective in addressing pathologies that result from viral infections in different aspects.
AB201 evaluated in Phase 1&2 in 700 subjects
So far, AB201 has been evaluated previously ion Phase 1&2 trials, which enrolled over 700 participants. It has also been tested in clinical studies for arterial and venous thrombosis prevention, where it demonstrated efficacy un tissue factor pathway inhibition and good tolerability at therapeutic doses.
According to recent research, the disease syndrome caused by SARS-CoV-2 could have similarities with other chronic infections where the infection processes result in inappropriate coagulation system activations and other immune response aspects that lead to serious complications. AB201 has shown to have anti-inflammatory and antiviral activity according to recent discoveries and data from past studies in non-human primates.