November 6, 2020 -- Senhwa Biosciences along with its clinical partner Center for Advanced Research and Education (CARE) in Gainesville, GA, received a "study may proceed" letter from the U.S. Food and Drug Administration (FDA) for its phase II investigator-initiated trial. The trial will evaluate the effectiveness of silmitasertib, an orally available casein kinase 2 inhibitor, to treat moderate COVID-19 patients.
The single-center, open-label, randomized-controlled interventional prospective study is expected to enroll 20 patients with moderate COVID-19. Silmitasertib challenges both SARS-CoV-2's ability to replicate quickly and spread to nearby healthy cells as well as the body's uncontrolled inflammatory response to SARS-CoV-2 infection. Silmitasertib targets the host protein kinase CK2 pathway so virus mutations are unlikely to affect either Silmitasertib's anti-viral or anti-inflammatory efficacy.
In other news, a separate phase II, investigator-initiated, clinical protocol will be led by Dr. Marilyn Glassberg Csete of the University of Arizona College of Medicine. That trial will enroll 40 patients hospitalized with COVID-19 once the FDA authorizes it.