Senhwa Biosciences has announced that its oral drug, Silmitasertib, has received positive feedback from an independent Data Monitoring Committee (DMC) in an interim review of Phase II investigator-initiated trial in patients with severe Covid-19.
Claimed to have high clinical potential to treat Covid-19, Silmitasertib acts on the protein kinase CK2 pathway.
As a CK2-inhibitor, it is believed to hinder the active viral replication in the infected cells to prevent the virus from spreading to nearby cells.
Furthermore, it reduces the overactive inflammatory response of the body to Covid-19.
The Phase II trial was conducted at Banner Health-University Medical Center in Phoenix, Arizona and Banner Health-University Medical Center in Tucson, Arizona, US.
The DMC, also called as the Data and Safety Monitoring Board, is an independent panel of clinical experts.
It evaluates patient safety and treatment efficacy data when clinical trials are underway.
The committee carried out an analysis on 11 March and reviewed the results from the first set of randomised subjects.
Following the initial evaluation, the DMC had stated that the trial did not require alterations.
On 23 August, the DMC carried out additional interim data assessment of 20 subjects.
The evaluation is claimed to bolster the decision to advance with the subject enrolment as per the overall trial design without any protocol changes.
Senhwa Biosciences CEO Tai-Sen Soong said: “We are pleased to know that DMC did not raise any safety concerns for Silmitasertib and patient enrolment can advance as per the protocol.”
Claimed to be safe, Silmitasertib can be administered easily due to its oral form.
Silmitasertib is being offered under compassionate use for severe Covid-19 patients in Taiwan since June this year.
Earlier in August, Senhwa Biosciences completed enrolment in Phase II investigator-initiated trial of Silmitasertib for Covid-19 treatment in the US.
The firm had enrolled 20 subjects suffering with moderate Covid-19 at two clinical centres in the US.