The trial will assess if early intervention with Silmitasertib can prevent the CAP progression linked to viral infections. Credit: fizkes / Shutterstock.

Senhwa Biosciences has dosed the first subject in a Phase II clinical trial of Silmitasertib (CX-4945) to treat community-acquired pneumonia (CAP) linked to viral infections in Taiwan.

The multicentre, randomised, controlled interventional prospective trial aims to determine if early intervention with Silmitasertib can prevent the CAP progression by curbing the cytokine release linked to SARS-CoV-2 and influenza viruses.

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This Phase II trial is spearheaded by a collaborative inter-hospital team experienced in conducting large-scale international clinical studies for antiviral drugs.

The team comprises specialists from five hospitals, including National Taiwan University Hospital, National Taiwan University Cancer Center, Far Eastern Memorial Hospital, Tri-Service General Hospital, and Taoyuan General Hospital, Ministry of Health and Welfare.

The intervention with Silmitasertib is intended to halt the progression of CAP, potentially reducing hospital admissions and enhancing patient outcomes.

In December 2023, the Taiwan Food and Drug Administration (FDA) granted clearance for the company’s investigational new drug application (IND) to commence a Phase II trial of Silmitasertib for treating CAP caused by viral infection.

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Before this, the US FDA granted IND clearance last November to commence a Phase II trial of Silmitasertib. 

These developments came after Senhwa had dosed the first subject in a Phase II trial of the therapy in adult Covid-19 patients admitted to the hospital. 

The trial is progressing in National Cheng Kung University Hospital in Taiwan. 

Through this proof-of-concept (PoC) trial, the company plans to validate the therapy as an effective treatment approach for various immune diseases.