Pharma Focus Asia

Senhwa Biosciences Granted FDA Approval for Silmitasertib Phase II Study in Viral CAP

Wednesday, November 22, 2023

Senhwa Biosciences, Inc. (TPEx: 6492) has disclosed that its Phase II Investigational New Drug (IND) application for Silmitasertib (CX-4945) has been approved by the U.S. Food and Drug Administration. This phase focuses on evaluating the efficacy of Silmitasertib in treating community-acquired pneumonia (CAP) caused by viral infection. The trial is a randomized-controlled interventional study aiming to determine if early intervention with Silmitasertib can impede the progression of CAP by inhibiting the cytokine release associated with SARS-CoV-2 and Influenza viruses.

Silmitasertib operates by inhibiting CK2 protein kinase, a key regulator of various 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 demonstrated in previous studies (Rosenberger et al.). Silmitasertib treatment also lowers the expression of TNF-α and CCL4 in NiSO4-stimulated MoDCs (Bourayne et al.). Senhwa Biosciences, Inc.'s CEO, Jin-Ding Huang, sees this Phase II study as a proof-of-concept demonstrating Silmitasertib's potential as a therapeutic strategy applicable to various viral infections.

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

Before this Phase II study, Silmitasertib underwent investigation in two investigator-initiated trials (IIT) in the United States, showcasing clinical benefits by accelerating recovery in patients with moderate COVID-19 symptoms.

Silmitasertib, a small molecule drug targeting the CK2 protein as a CK2 inhibitor, has shown safety and tolerance in humans through clinical studies. Administered orally, it is currently under development for oncology programs in adults and children with recurrent/advanced or metastatic cancer. Three Phase I trials and one Phase II trial in cancer patients have been completed, with two additional Phase I and II studies ongoing.

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



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