Senhwa Biosciences has reported preliminary positive efficacy and safety data from the Phase II clinical trial of its oral antiviral therapy, Silmitasertib, in moderate Covid-19 patients.
Targetting host cell protein called Casein Kinase 2, the antiviral is an experimental anti-inflammatory treatment and could potentially be effective against the emergent variants of the SARS-CoV-2 virus.
The two-arm, parallel-group, open-label, investigator-initiated, randomised, controlled, interventional trial is assessing the safety, tolerability and pharmacokinetics of a twice-daily dose of 1,000mg Silmitasertib in subjects with moderate Covid-19.
Carried out at two US trial centres, the trial enrolled 20 subjects, who were randomised into a 1:1 ratio to receive either Silmitasertib plus standard of care (SOC)/best supportive care or SOC/best supportive care alone for 14 days.
Silmitasertib demonstrated a statistically significant and clinically meaningful 133% quicker time to Covid-19-associated clinical symptoms recovery as against SOC/ best supportive care.
Furthermore, the therapy provided a 114% quicker time to attain EQ-5D-5L Q6 ≥ 90% and 57% faster time to resolution of disease-linked clinical signs compared to SOC/best supportive care.
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It was also demonstrated to be well tolerated with a good safety profile.
No severe adverse events (SAEs) linked to the Silmitasertib treatment arm were reported in the trial.
The company will share the latest results with the US National Institute of Health for further analysis under the ACTIV programme.
Senhwa Biosciences CEO Tai-Sen Soong said: “We are very pleased with the preliminary results of this Phase II study, which demonstrated a statistically significant and clinically meaningful improvement in relevant endpoints, including time to clinical symptoms recovery and normalisation of clinical signs.
“We believe Silmitasertib in its significant potential in treating Covid-19, both as an antiviral and anti-inflammatory agent.”
Last month, Senhwa’s Silmitasertib received positive feedback from an Independent Data Monitoring Committee for their interim analysis of a Phase II trial in severe Covid-19 patients.