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September 1, 2021

Senhwa receives approval to progress Phase II trial of Silmitasertib

As no safety issues linked to the drug were raised by the committee, subject recruitment can progress without modifications.

Senhwa Biosciences has reported that its oral drug, Silmitasertib, obtained positive feedback from an Independent Data Monitoring Committee (DMC) for their interim analysis of a Phase II clinical trial in severe Covid-19 patients.

Silmitasertib acts on the protein kinase CK2 pathway and is said to have high clinical potential to treat Covid-19.

The CK2-inhibitor can potentially hinder the active viral replication in the infected cells to prevent the SARS-CoV-2 virus from spreading to neighbouring cells. It additionally lowers the overactive inflammatory response of the body to Covid-19.

The investigator-initiated Phase II trial was carried out at Banner Health-University Medical Centers in Phoenix and Tucson, Arizona, US.

An independent panel of clinical experts, the DMC, also called the Data and Safety Monitoring Board assesses the patient safety and treatment efficacy findings when clinical trials are underway.

Initially, the committee conducted an analysis on 11 March and reviewed results from the first set of randomised subjects. The DMC had found that the Phase II trial did not require alterations.

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On 23 August, the DMC conducted further interim data assessment of 20 subjects.

The analysis is said to boost the decision to progress with the subject enrolment according to the overall trial design without requiring 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.”

Silmitasertib is safe and can be administered easily because of its oral form, the company noted.

Furthermore, the drug is offered under compassionate use for severe Covid-19 patients in Taiwan since June.

The latest development comes after Senhwa Biosciences concluded enrolment in the Phase II investigator-initiated trial of 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 country.

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