Arca Biopharma Inc (NASDAQ: ABIO) announced its ASPEN-COVID-19 results. The phase IIb study had 160 patients and investigated rNAPc, that treats patients with COVID-19. This drug is a tissue factor inhibitor.
Results showed that the two doses of rNAPc2 that the researchers gave benefited the patients. However, none of the individual doses had statistical significance for the eight days of treatment compared to heparin, the standard treatment.
How researchers conducted the trial
The researchers gave rNAPc2 in a low dose, high dose, and hepatic in about 93% of patients. They administered heparin as a prophylactic dose. The patients got rNAPc2 on the first, third, and fifth days. Researchers administered hepatic on the third day.
The team designed the study in a way that allowed them to comprehend how safe the doses were in comparison with heparin. It was also to look into the efficacy of the drug. These results would set the stage for a Phase III clinical trial.
According to the CEO and Chairman of ARCA Biopharma, Michael Bristow, M.D., mounting evidence has shown the relationship of thrombosis in patients with COVID-19. However, the company was disappointed by the trial results as rNAPc2 did not show significant benefits to patients compared to heparin which is the standard care.
The trial results were disappointing
Despite the negative results, the company has appreciated the patients and researchers who were part of the study. Furthermore, ARCA Biopharma will keep analyzing the analyses of the clinical trial, including the antiphospholipid Abs measurements.
The company has stated that it will not develop rNAPc2 as a superior alternative to heparin. However, they could design a study on the drug’s efficacy when given with prophylactic heparin.
An executive committee member of the study, Wolfram Ruf, M.D., the drug’s efficacy in reducing arterial and venous thrombotic events like heparin indicates that tissue factors drive the coagulopathy observed in patients with severe COVID-19.
Another member of the committee, Marc Bonaca, M.D., the findings show a good safety profile of the drug compared to heparin. Even though rNAPc2 did not have a significant effect on D-dimer, Bonaca explains that its findings in patients with advanced COVID-19 where heparin was ineffective shows promise.
