TAIPEI and SAN DIEGO, Oct. 19, 2023 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that it has submitted an Investigational New Drug (IND) application to U.S. Food and Drug Administration to evaluate its investigational drug, Silmitasertib(CX-4945), for treating patients with community-acquired pneumonia (CAP) caused by viral infection. The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether early intervention of Silmitasertib restrains the progression of CAP by inhibiting the elevated cytokine release associated with SARS-CoV-2 and Influenza viruses.
Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses. CK2 modulates inflammatory pathways, including NF-κB, PI3K–Akt–mTOR, and JAK–STAT. Inhibition of CK2 by Silmitasertib diminishes the secretion of IL-6 and MCP-1 (Rosenberger et al.). Silmitasertib treatment also reduces the expression of TNF-α and CCL4 in NiSO4-stimulated MoDCs (Bourayne et al.). 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. The global market for related therapeutic drugs has exceeded a value of over $1.3 billion USD in 2021 and it's projected to grow at a CAGR of 7.70% and reach more than $2.4 billion USD by 2029 according to market research.
Prior to this 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 moderate 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 and that greatly increases the risk of death in populations with immunodeficiency, cancer, or other chronic illnesses. Therefore, the development of therapeutics that can effectively tackle the complications caused by viral infection and reduce the chance of severe immune response and mortality is still urgently needed.