Senhwa Biosciences Received Taiwan FDA IND Approval for Phase II Study of Silmitasertib in Patients with Moderate to Severe COVID-19

TAIPEI and SAN DIEGO, April 28, 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 Taiwan FDA has approved its Phase II IND application of Silmitasertib(CX-4945) to treat hospitalized patients with moderate to severe COVID-19. Senhwa will proceed with the patient enrollment once receiving approval from the IRB.

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. 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 Syncytical Virus (RSV). Senhwa regards this phase II as the  proof of concept study  to demonstrate  Silmitasertib can be a therapeutic strategy that would not be restricted to only  a specific viral infection, but applicable to different viruses. The global market for related therapeutic drugs has already exceeded a value of over $10 billion USD.

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 either mild, moderate or severe symptoms of COVID-19.

As an impact of  the decrease in immunity after COVID-19 infection, the complications caused by respiratory diseases will be more likely to occur that greatly increases the risk of death in populations with immunodeficiency, cancer, or chronic illness histories. Therefore, the world is still under the threat of another outbreak. The development of therapeutics that can effectively tackle viral infection and reduce the risk of severe immune response and mortality is still urgently needed.

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.