Senhwa Biosciences has concluded enrolment in Phase II investigator-initiated trial (IIT) of its oral drug, Silmitasertib, for Covid-19 treatment in the US.
A total of 20 subjects with moderate Covid-19 were enrolled at two clinical centres in the US.
Silmitasertib acts on the protein kinase CK2 pathway and is believed to have high clinical potential to treat Covid-19, the company noted.
The open-label, randomised, two-arm, parallel-group controlled Phase II trial is investigating the safety, tolerability and pharmacokinetics of a twice-daily 1000mg dose of Silmitasertib in subjects with moderate Covid-19.
It will analyse the time to clinical recovery and benefit across the treatment arms.
Senhwa Biosciences chief medical officer Dr John Soong said: “The Delta variant or any other variant strains are unlikely to affect either the anti-viral or anti-inflammatory efficacy of Silmitasertib since it does not directly target coronavirus proteins, but the host protein kinase CK2 pathway, which the virus uses to replicate.
“CK2 protein kinase does not mutate and as such, it is an excellent target for the design of a potent antiviral agent.”
The company added that the drug was safe and can be administered easily due to its oral form.
Furthermore, Silmitasertib demonstrated the ability to hinder viral replication in infected cells and reduce the body’s overactive inflammatory response to Covid-19 in preclinical studies.
Another Phase II IIT of the drug is currently progressing in the US to treat severe Covid-19 patients.
Separately, Silmitasertib was included in Taiwan’s Center for Drug Evaluation: ‘CDE can Help: COVID-19 Regulatory Consultation Program’ to develop the drug for the treatment of Covid-19 in Taiwan.
Senhwa Biosciences CEO Tai-Sen Soong said: “Under the guidance of Taiwan’s CDE, Senhwa plans to launch a Covid-19 clinical trial in Taiwan to further examine the safety and human efficacy of Silmitasertib in treating Covid-19.”
Silmitasertib is currently offered under compassionate use for severe Covid-19 patients in Taiwan.
In June 2021, Senhwa filed an investigational new drug application seeking India’s Central Drugs Standard Control Organization’s approval to initiate a Phase II trial of Silmitasertib for Covid-19.