Therapy Areas: Inflammatory Diseases
First Patient Enrolled in an Investigator Initiated Trial of Silmitasertib as a Treatment for Patients with Severe COVID-19
22 January 2021 - - The first patient has enrolled into an investigator-initiated trial of Taipei-based biopharmaceutical company Senhwa Biosciences, Inc's (TPEx: 6492) investigational drug, Silmitasertib, as a treatment for hospitalized COVID-19 patients at Banner Health-University Medical Center in Phoenix, Arizona (BUMCP), the company said.

This IIT is a Phase II multi-center, open-label, randomized, controlled interventional prospective study. BUMCP intends to enroll 40 patients with severe COVID-19, where half will receive Silmitasertib for 14 days.

Senhwa's Silmitasertib is an oral medication, targeting the host protein kinase CK2 (casein kinase 2), where virus mutations are unlikely to affect its anti-viral and anti-inflammatory efficacy.

It is thought that Silmitasertib challenges the virus' ability to replicate quickly and spread to nearby healthy cells.

A separate Phase II IIT for outpatient adult subjects with moderate COVID-19 is currently underway and is being led by Dr. Chris Recknor at the Center for Advanced Research and Education in Gainesville, Georgia. Dr. Recknor's trial enrolled their first patient on December 3, 2020.

Silmitasertib is a first-in-class small molecule drug that targets CK2 and acts as a CK2-inhibitor. Silmitasertib is safe and well-tolerated in humans. To date, three Phase I trials of Silmitasertib in cancer patients have been completed; currently, there is one ongoing Phase I and two ongoing Phase II studies.

In December 2016, Silmitasertib was granted Orphan Drug Designation by the US FDA for the treatment of Cholangiocarcinoma. In July 2020, Silmitasertib was granted Rare Pediatric Disease Designation to treat Medulloblastoma by the US FDA.

An eIND was granted by the US FDA on August 27, 2020, to Dr. Rayyan at BUMCP to treat a patient with severe COVID-19.

Senhwa Biosciences is a clinical-stage company focusing on developing first-in-class, next-generation DDR therapeutics for patients with unmet medical needs in oncology.

Headquartered in Taiwan, with an operational base in San Diego, California, Senhwa is positioned to oversee the development of its compounds.

Development is currently focused on two lead products: Silmitasertib (CX-4945) and Pidnarulex (CX-5461), both with novel mechanisms of action and for multiple indications. Clinical trials are currently ongoing in Australia, Canada, United States, Korea, and Taiwan.
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