Senhwa Biosciences, Inc. announced the positive efficacy and safety results from an investigator-initiated, Phase 2 clinical trial of Silmitasertib in approximately 20 patients with moderate COVID-19. The efficacy and safety of Silmitasertib was evaluated in a randomized, open-label, 2 arm parallel-group controlled interventional prospective phase 2 study conducted in two sites in the US. Participants were randomized if they had signs or symptoms of moderate COVID-19 and a positive SARS-CoV-2 RT-PCR or equivalent testing. 20 participants were randomized in a 1:1 ratio to receive 1,000 mg BID oral dose Silmitasertib in addition to SOC/best supportive care or SOC/best supportive care alone for 14 days. During the study, no patients on the Silmitasertib arm received concomitant COVID-19 therapies. Currently, Senhwa Biosciences is the only Taiwanese based company to demonstrate human efficacy against SARS-CoV-2 with its investigational anti-COVID-19 therapy. Silmitasertib targets host cell protein, Casein Kinase 2, and this unique and strategic clinical approach is expected to be effective against the emerging SARS-CoV-2 variants. Complete safety and efficacy data will be presented after completion of this Phase 2 study. Efficacy Endpoints: In the Intent to Treat (ITT) population, Silmitasertib showed a statistically significant and clinically meaningful 133% faster time in recovery of COVID-19-related clinical symptoms (Median: 6 days vs 14 days, p=0.0167, one-sided Type-1 error 0.20), 114% faster in time to reach EQ-5D-5L Q6 = 90% versus SOC/best supportive care (Median: 14 days vs 30 days, p=0.1835, one-sided Type-1 error 0.20) and 57% faster in time to normalization of COVID-19 related clinical signs versus SOC/best supportive care (Median: 7 days vs 11 days, p=0.0557, one-sided Type-1 error 0.20). Safety Endpoint: Silmitasertib was well tolerated with a good safety profile. No SAEs related to Silmitasertib treatment group were observed. Silmitasertib and SOC/Best Supportive Care: The efficacy and safety of Silmitasertib was evaluated in a randomized, open-label, 2 arm parallel-group controlled interventional prospective phase II study conducted in two sites in the US. Participants were randomized if they had signs or symptoms of moderate COVID-19 and a positive SARS-CoV-2 RT-PCR or equivalent testing. 20 participants were randomized in a 1:1 ratio to receive 1,000 mg BID oral dose Silmitasertib in addition to SOC/best supportive care or SOC/best supportive care alone for 14 days. During the study, the standard of care included treatment with dexamethasone and/or other therapies under an Emergency Use Authorization. No patients on the Silmitasertib arm received concomitant COVID-19 therapies.