Taiwan FDA has granted clearance for Senhwa Biosciences’ investigational new drug (IND) application to initiate a Phase II clinical trial of Silmitasertib(CX-4945) to treat hospitalised patients with moderate to severe Covid-19.
Senhwa plans to initiate patient enrolment, upon receiving approval from the IRB.
In this Phase II proof of concept trial, Senhwa aims to demonstrate Silmitasertib as a therapeutic strategy that would not be restricted to just one specific viral infection, but applicable to several viruses.
Silmitasertib inhibits CK2 protein kinase which implicates regulation of several signaling pathways that are important for innate immune responses.
CK2 inhibitors dampen NF-κB activation in macrophages and consequent IL-1, IL-6 and IL-10 cytokine secretion by these cells.
CK2 inhibition further boosts type I IFN production in macrophages in viral infection settings.
The approach of Silmitasertib targeting host cell CK2 protein against the SARS-CoV-2 variants is also expected to be clinically effective against other viruses including influenza and Respiratory Syncytical Virus (RSV).
Silmitasertib also showed clinical benefits by expediting the recovery speed in patients with either mild, moderate or severe symptoms of Covid-19 in two investigator-initiated trials (IIT) in the US.
Covid-19 infections might also increase the risk of death in populations with cancer, immunodeficiency, or chronic illness histories.