Senhwa Biosciences, Inc. announced 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-B,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- 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. 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. Silmitasertib is currently under development through several oncology programs in adults and children with recurrent/advanced or metastatic cancer.

To date, three Phase I trials and one Phase II trial of Silmitasertib in cancer patients have been completed while two other Phase I and II studies of Silmitasertib are still ongoing. The US FDA has granted Silmitasertib Orphan Drug Designation for the treatment of Cholangiocarcinoma in December 2016, Rare Pediatric Disease Designation and Orphan Drug designation for the treatment of Medulloblastoma in July 2020 and December 2021, respectively. Fast Track Designation was granted in August 2021 for the treatment of recurrent Sonic Holehog driven Medulloblastoma.