Senhwa Biosciences Announces First Patient Successfully Dosed in Taiwan Phase II Study of Silmitasertib in Hospitalized Adults with COVID-19

TAIPEI and SAN DIEGO, Nov. 9, 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 their first patient has been successfully dosed in Taiwan Phase II Study of Silmitasertib (CX-4945) in Hospitalized Adults with COVID-19. The study is conducted in National Cheng Kung University Hospital.

Prior to this COVID-19 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  mild, moderate or severe symptoms of COVID-19. Silmitasertib targets host cell CK2 protein and this unique approach is expected to be clinically effective against the SARS-CoV-2 variants and other viruses such as influenza and Respiratory Syncytial Virus (RSV).

According to the latest publication "Risk of autoimmune diseases in patients with COVID-19" published in eClinicalMedicine, part of The Lancet Discovery Science, found that COVID-19 is associated with a different degree of risk for various autoimmune diseases. Their findings showed that the COVID-19 cohort exhibited significantly higher risks of rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, and other autoimmune diseases versus those without COVID-19 in the study. Viruses play a significant role in the environmental factors that affect human immune system and now SARS-CoV-2 has the potential to be added to the list.     

Silmitasertib works by inhibiting CK2 protein kinase, which have implicated in regulation of several signaling pathways that are important for innate immune responses. CK2 inhibitors dampened NF-κB activation in macrophages and consequent IL-1, IL-6 and IL-10 cytokine secretion by these cells in response to viral infection. In viral infection settings, CK2 inhibition also reportedly boosts type I IFN production in macrophages. Senhwa regards this phase II trail as proof of concept study to demonstrate Silmitasertib can be a therapeutic strategy that would be effective in treating immune diseases and the global value of the relevant treatment has reached 100 billion US dollars, which is the second largest drug market after cancer.

About Silmitasertib
Silmitasertib is a first-in-class small molecule drug that targets the CK2 protein and acts as a CK2 inhibitor.  Clinical studies thus far have shown Silmitasertib is safe and well-tolerated in humans and is easily administered with its oral formulation. 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 Hedgehog driven Medulloblastoma.

About Senhwa Biosciences
Senhwa Biosciences, Inc. is a leading clinical-stage company focused on developing first-in-class, next-generation DNA Damage Response therapeutics and seeks to address unmet medical needs in oncology and infectious diseases.  Headquartered in Taiwan, with an operational base in San Diego, California, Senhwa is well-positioned to oversee the development of its compounds.

Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action as anti-cancer drugs for the treatment of multiple indications, are the core products in Senhwa Bioscience's pipeline. Clinical trials are currently ongoing in Australia, Canada, United States and Taiwan.

Visit Senhwa Biosciences' website for more details: www.senhwabio.com

SOURCE Senhwa Biosciences, Inc.