Based in Westminster, Colorado, ARCA biopharma (NASDAQ:ABIO) announced a new development program for the treatment of coagulopathy, or abnormal blood clotting, in patients with COVID-19. COVID-19 associated coagulopathy (CAC) has been one of the most serious adverse effects observed in COVID-19 patients around the world. It can result in the incidence of strokes, heart attacks, pulmonary emboli, or disseminated intravascular coagulation (DIC).
According to the company, recent research has suggested that COVID-19 has multiple factors in common with blood disorders in which blood clotting is impaired. The company’s AB201 experimental drug is a tissue factor (TF) inhibitor that has been found to play an important role in the viral infection process and the associated inflammatory response including virus-associated coagulopathy.
Safety data for other indications supports accelerated development
ARCA has thus far generated safety data involving over 700 patients with indications other than COVID-19 as part of a phase 2 clinical study. In those trials AB201 was shown to have effectively inhibited the blood clotting process. The program’s prior results involving the treatment of Ebola and Marburg viral infections in non-human primates suggest that the therapy is worthy of further development for RNA virus associated disease.
President and CEO Dr. Michael Bristow, a COVID-19 investigator funded by the American Heart Association (AHA), 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 effect and antiviral activity have the potential to make AB201 a unique therapeutic to treat patients with COVID-19 while vaccine development is underway and for patients for whom a vaccine is not effective.”
Dr. Bristow also noted that the therapy may be able to address future outbreaks of diseases related to other ribonucleic acid (RNA) viruses.
The company is working with the University of Colorado Academic Research Organization to develop a phase 2B/3 clinical trial protocol for hospitalized COVID-19 patients with blood clotting issues. It noted that the potential efficacy of AB201 would not be affected by the mutations of the SARS CoV-2 virus and could also be effective against other coagulopathy-related viruses.
The strong safety data may lead to a fast timetable for the development of the COVID-19 coagulopathy treatment. ARCA plans to file an investigational new drug (IND) application with the U.S. Food & Drug Administration (FDA) in the third quarter of this year. It also expects to commence late-stage clinical testing in the second half of the year pending FDA approval and the obtainment of trial funding.
The volatile small cap biotechnology stock skyrocketed approximately 400% on May 28th in response to the announcement. On April 4th the company issued a 1 for 18 reverse stock split, its third reverse share split since 2013. ARCA is scheduled to report third quarter financial results and provide a business update on August 6th.