Senhwa Biosciences Announces IND Submission to US FDA for Phase II Study of Silmitasertib in Patients with Community-Acquired Pneumonia (CAP) Associated with Viral Infection

TAIPEI and SAN DIEGO, Oct. 19, 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 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-κB, 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-α 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. The global market for related therapeutic drugs has exceeded a value of over $1.3 billion USD in 2021 and it's projected to grow at a CAGR of 7.70% and reach more than $2.4 billion USD by 2029 according to market research.

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.

As an impact of the decrease in immunity after COVID-19 infection, the complications caused by respiratory diseases will be more likely to occur and that greatly increases the risk of death in populations with immunodeficiency, cancer, or other chronic illnesses. Therefore, the development of therapeutics that can effectively tackle the complications caused by viral infection and reduce the chance 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.