TAIPEI and SAN DIEGO, Sept, 27, 2021-- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today announced the acceptance of early positive Phase 2 efficacy and safety data abstract for Silmitasertib in moderate COVID-19 patients at the ISIRV-WHO Virtual Conference-COVID-19, Influenza and RSV: Surveillance-informed prevention and treatment being held on 19-21 October, 2021. The ongoing Phase 2 trial data will be presented at the conference.
The conference will address the evolution, epidemiology and impact of SARS-CoV-2, influenza, RSV and other respiratory viruses, implications for surveillance strategies and progress on vaccines, antivirals, immunomodulators and other countermeasures.
“We are very pleased with the early efficacy and safety results of this Phase 2 study, which demonstrated statistically significant and clinical meaningful reduction in relevant endpoints, including time to recovery and normalization of clinical signs. We believe Silmitasertib in its significant potential in treating COVID-19, both as antiviral and anti-inflammatory agent, helping to prevent effects that lead to severity or death,” said Tai-Sen Soong, Chief Executive Officer of Senhwa Biosciences.
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.
Senhwa Biosciences is the first and only Taiwan 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.