The US Food and Drug Administration (FDA) has granted approval for Senhwa Biosciences’ investigational new drug application (IND) to commence a Phase II clinical trial of Silmitasertib (CX-4945) for the treatment of community-acquired pneumonia (CAP) caused by viral infection. 

The interventional, multicentre, randomised, controlled trial will analyse whether early treatment with Silmitasertib hinders CAP progression by preventing the higher release of cytokine linked to the SARS-CoV-2 and Influenza viruses.

Senhwa Biosciences CEO Jin-Ding Huang said: “Senhwa regards this Phase II as the proof-of-concept study to demonstrate Silmitasertib can be a therapeutic strategy that are not restricted to only a specific viral infection, but applicable to various viruses.”

Silmitasertib hinders CK2 protein kinase, which is associated with the regulation of various signalling pathways that are vital for innate immune responses.

Inflammatory pathways, including NF-κB, PI3K–Akt–mTOR, and JAK–STAT, are modulated by CK2. Hindering this protein kinase using Silmitasertib is said to reduce the secretion of IL-6 and MCP-1. 

In addition, the therapy could also diminish the expression of TNF-α and CCL4 in NiSO4-stimulated MoDCs. 

The investigational therapy had been demonstrated to offer clinical benefits in expediting the speed of recovery in moderate Covid-19 patients in two investigator-initiated trials (IIT) in the US.

The development comes after Senhwa dosed the first patient in a Phase II trial of Silmitasertib in adults with Covid-19 admitted to the hospital. This trial is underway in National Cheng Kung University Hospital, in Taiwan.

In May this year, the Taiwan FDA granted IND clearance for the launch of this trial in Covid-19 patients.