Senhwa Biosciences Received Taiwan FDA IND Approval for Phase II Study of Silmitasertib in Patients with Moderate to Severe COVID-19
Senhwa Biosciences, a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that Taiwan FDA has approved its Phase II IND application of Silmitasertib (CX-4945) study to treat hospitalized patients with moderate to severe COVID-19. Senhwa will proceed with the patient enrollment once receiving approval from the IRB.
Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses. CK2 inhibitors dampened NF-κB activation in macrophages and consequent IL-1, IL-6 and IL-10 cytokine secretion by these cells in response to viral infection. In viral infection settings, CK2 inhibition also reportedly boosts type I IFN production in macrophages. Silmitasertib targets host cell CK2 protein and this unique approach is expected to be clinically effective against the SARS-CoV-2 variants and other viruses such as influenza and Respiratory Syncytical Virus (RSV). Senhwa regards this phase II as the proof of concept study to demonstrate Silmitasertib can be a therapeutic strategy that would not be restricted to only a specific viral infection, but applicable to different viruses. The global market for related therapeutic drugs has already exceeded a value of over $10 billion USD.
Prior to this COVID-19 phase II study, Silmitasertib was investigated in two investigator-initiated trials (IIT) in the United States and has showed clinical benefits by accelerating the recovery speed in patients with either mild, moderate or severe symptoms of COVID-19.
As an impact of the decrease in immunity after COVID-19 infection, the complications caused by respiratory diseases will be more likely to occur that greatly increases the risk of death in populations with immunodeficiency, cancer, or chronic illness histories. Therefore, the world is still under the threat of another outbreak. The development of therapeutics that can effectively tackle viral infection and reduce the risk of severe immune response and mortality is still urgently needed.
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