US FDA Approves Senhwa's Phase II IND Application of Silmitasertib

Senhwa Biosciences, Inc., a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced that the US Food and Drug Administration has approved Silmitasertib (CX-4945)'s phase II IND application to treat patients with community-acquired pneumonia (CAP) caused by viral infection. The trial is a phase II multi-center, randomized-controlled interventional prospective study to see if early intervention with Silmitasertib slows the progression of CAP by inhibiting the elevated cytokine release associated with the SARS-CoV-2 and Influenza viruses.

Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signalling pathways that are important for innate immune responses.  CK2 modulates inflammatory pathways, including NF-?B, PI3K–Akt–mTOR, and JAK–STAT. Inhibition of CK2 by Silmitasertib diminishes the secretion of IL-6 and MCP-1 (Rosenberger et al.), as per pharmabiz. 

Silmitasertib therapy also lowers TNF-a and CCL4 expression 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," stated Jin-Ding Huang, president and CEO of Senhwa

According to market research, the global market for related therapeutic pharmaceuticals topped $120.6 billion USD in 2020 and is expected to expand at a CAGR of 7.88% to more than $339 billion USD by 2030.

Prior to this phase II investigation, Silmitasertib was explored in two investigator-initiated trials (IIT) in the United States, where it demonstrated therapeutic advantages by hastening recovery in individuals with moderate Covid-19 symptoms.