ARCA Biopharma Inc. (NASDAQ:ABIO) has announced that it has received FDA approval for its Investigational New Drug application for AB201 (rNAPc2) as a potential COVID-19 treatment for Hospitalized patients.
ARCA to commence Phase 2b/3 ASPEN-COVID-19 study
The company plans to commence Phase 2b/3 consecutive clinical ASPEN-COVID-19 study of AB201 in around 100 hospitalized patients with COVID-19 in Q4 2020. The Phase 2b trial will be followed with a contagious third phase study based on phase 2 results. ARCA expects to report topline results from the study in Q2 2021.
The phase 2b study will be randomized into two dose treatments of AB201 against heparin as prescribed per standard of care. It is important to note that some COVID-19 patients’ clinical course is complicated through virus-prompted coagulopathy, including inflammatory processes and thrombotic events, which is thought to be mediated by tissue factor production. The study’s primary endpoint will be D-dimer level change from baseline to the eighth day.
ARCA to start enrolment in phase 3 after reviewing of results
D-dimer is a commonly used biomarker employed in evaluating coagulation activation whose levels are elevated in almost 50% of hospitalized patients with COVID-19. It is related to adverse clinical outcomes. The company expects to commence enrolment of subjects in Phase 3 trials if the second phase shows favourable effect on D-dimer levels. This is after the FDA has reviewed the results and the company identifies the AB201 dose for expected third phase. Phase 3’s primary endpoint will be clinical recovery. Secondary endpoints will be the number of thrombotic events and D-dimer levels.
Michael Bristow, the CEO and President of the company, said that the ASPEN-COVID-19 study will use coagulopathy D-dimer biomarker in identifying optimal AB201 doses regimens. The doses will be within the therapeutic range determined in Phase 2 studies evaluating cardiovascular thrombosis prophylaxis. Bristow stated that is the study will be successful; they plan to use the dose in the anticipated phase 3 study evaluating potential enhancement of clinical outcomes.