Pharma Focus Asia

Senhwa Biosciences Starts Phase II Study of Silmitasertib for Community-Acquired Pneumonia with Viral Infection in Taiwan

Thursday, March 21, 2024

Senhwa Biosciences, Inc. (TPEx: 6492), a pharmaceutical company specializing in novel therapeutics for oncology, rare diseases, and infectious diseases, has announced a significant milestone today. The company has successfully administered the first dose to a patient in the phase II trial of Silmitasertib (CX-4945) for treating community-acquired pneumonia (CAP) associated with viral infection in Taiwan. This trial aims to assess whether early intervention with Silmitasertib can halt the progression of CAP by targeting the heightened release of cytokines linked with SARS-CoV-2 and Influenza viruses.

Leading this phase II trial is an esteemed inter-hospital team specializing in infectious diseases, comprising five reputable 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 recent warning issued by the World Health Organization (WHO) regarding the potential resurgence of a pandemic, dubbed Disease X, underscores the urgency of developing effective treatments. This threat may arise from the evolution of influenza strains, novel coronaviruses, or entirely new pathogens. Notably, the WHO's risk assessment following the first human case of avian flu and subsequent fatality in mainland China earlier this year has heightened concerns.

Silmitasertib (CX-4945), developed by Senhwa Biosciences, offers a promising solution with its unique mechanism targeting human host cells, thereby reducing susceptibility to viral mutations. The objective of this trial is to provide early medical intervention using Silmitasertib to prevent CAP progression, minimize hospitalizations, improve clinical outcomes, and mitigate risks associated with cytokine release during infections by emerging coronaviruses or influenza viruses.

Furthermore, Senhwa Biosciences is advancing CX-8184, a next-generation drug exhibiting superior antiviral activity and enhanced neutralizing capabilities against viruses. This drug is being developed for direct administration to the lungs, aiming to offer a convenient and broad-spectrum antiviral treatment option upon successful completion of trials.

Silmitasertib is a groundbreaking small molecule drug that targets the CK2 protein, acting as a CK2 inhibitor. Clinical studies have demonstrated its safety and tolerability in humans, with easy oral administration. Silmitasertib is currently undergoing development across several oncology programs for both adults and children with recurrent/advanced or metastatic cancer. Notably, it has received Orphan Drug Designation from the US FDA for the treatment of Cholangiocarcinoma, Rare Pediatric Disease Designation, and Orphan Drug Designation for Medulloblastoma. Fast Track Designation was granted for the treatment of recurrent Sonic Hedgehog-driven Medulloblastoma.



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