Senhwa Presents Positive Data from Phase 2 Trial of Silmitasertib (CX-4945) in Treating Moderate COVID-19 Patients

Senhwa Presents Positive Data from Phase 2 Trial of Silmitasertib (CX-4945) in Treating Moderate COVID-19 Patients

Senhwa Biosciences presented positive efficacy and safety results from an investigator-initiated, Phase 2 clinical trial of Silmitasertib in patients with moderate COVID-19. The trial evaluated silmitasertib in addition to standard of care (SOC)/best supportive care (BSC) or SOC/BSCe 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. The patients in the Silmitasertib arm had statistically significant and clinically meaningful improvements in relevant endpoints, including time to clinical symptoms recovery and normalization of clinical signs compared to SOC/BSC alone.  

The randomized, open-label, 2 arm parallel-group controlled interventional prospective study was conducted at two sites in the US. The trial enrolled 20 patients with moderate COVID-19 who were randomized in a 1:1 ratio to receive 1,000 mg twice daily (BID) oral dose Silmitasertib in addition to SOC/best supportive care or SOC/best supportive care alone for 14 days. 

In the Intent to Treat (ITT) population, Silmitasertib sho...

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