Senhwa Biosciences, Inc. (TPEx: 6492), a company focused on drug development for oncology, rare diseases, and infectious diseases, has received approval from the Taiwan Food and Drug Administration for its Phase II Investigational New Drug (IND) application of Silmitasertib (CX-4945). This approval is for the treatment of community-acquired pneumonia (CAP) caused by viral infection. The Phase II trial is a multi-center, randomized-controlled prospective study designed to assess whether early intervention with Silmitasertib can impede the progression of CAP by inhibiting elevated cytokine release associated with SARS-CoV-2 and Influenza viruses.

Leading this trial is an inter-hospital team specializing in infectious diseases, with extensive experience in conducting large-scale international clinical trials. The team consists of experts from five prominent hospitals: 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.

Silmitasertib acts by inhibiting CK2 protein kinase, a regulator of signaling pathways crucial for innate immune responses. CK2 modulates inflammatory pathways, including NF-κB, PI3K–Akt–mTOR, and JAK–STAT. Inhibition of CK2 by Silmitasertib reduces the secretion of IL-6 and MCP-1, as shown in previous studies. The treatment also diminishes the expression of TNF-α and CCL4 in stimulated monocyte-derived dendritic cells. Senhwa Biosciences, Inc. CEO Jin-Ding Huang states that this Phase II trial serves as a proof-of-concept study to demonstrate Silmitasertib's potential as a therapeutic strategy applicable to various viruses, not limited to a specific viral infection.

The global market for related therapeutic drugs surpassed $120.6 billion USD in 2020 and is expected to grow at a CAGR of 7.88%, reaching over $339 billion USD by 2030, according to market research.

Silmitasertib is a first-in-class small molecule drug targeting the CK2 protein as a CK2 inhibitor. Clinical studies have demonstrated its safety and tolerability in humans, administered through an oral formulation. Currently, Silmitasertib is in development for various oncology programs addressing recurrent/advanced or metastatic cancer in both adults and children. Three Phase I trials and one Phase II trial have been completed, with two other Phase I and II studies ongoing.

Silmitasertib has received Orphan Drug Designation from the US FDA for treating Cholangiocarcinoma (December 2016), Rare Pediatric Disease Designation, and Orphan Drug Designation for treating Medulloblastoma (July 2020 and December 2021, respectively). Fast Track Designation was granted in August 2021 for treating recurrent Sonic Hedgehog-driven Medulloblastoma.

 

Source: prnewswire.com

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