CARE Receives May Proceed Letter from FDA for COVID-19 Trial

Senhwa Biosciences announced its clinical partner, Center for Advanced Research and Education (CARE) in Gainesville, Georgia, has received a Study May Proceed letter from the US Food and Drug Administration (FDA) to begin a phase II investigator-initiated trial (IIT) evaluating Silmitasertib, a novel orally available casein kinase 2 inhibitor to treat moderate COVID-19 patients.

"The FDA's clearance of our investigator-initiated trial application for Phase II testing in patients with COVID-19 is an important milestone for Silmitasertib, which represents a new paradigm in the treatment of viral diseases with dysregulated immune response," said Dr. John Soong, the Chief Medical Officer of Senhwa Biosciences. "The COVID-19 clinical trial is part of a broad systemic disease strategy designed to demonstrate Silmitasertib proof of concept in serious inflammatory diseases with critical medical need."

The planned investigator-initiated trial (IIT) is a phase II single-center, open-label, randomized-controlled interventional prospective study. It is expected to enroll 20 patients with moderate COVID-19.

"Health care systems around the world are being overwhelmed by SARS-CoV-2. Silmitasertib's mechanism of action by CK2 inhibition is a unique pathway to target SARS-CoV-2 infection that has promise to combat this disease," said Dr. Chris Recknor, the lead PI of this IIT trial.

Silmitasertib is an oral medication, which challenges both the virus' (SARS-CoV-2) ability to replicate quickly and spread to nearby healthy cells and the body's uncontrolled inflammatory response to SARS-CoV-2 infection. Because Silmitasertib targets the host protein kinase CK2 (f.k.a. casein kinase 2) pathway, virus mutations are unlikely to affect either Silmitasertib anti-viral or anti-inflammatory efficacy.

A separate Phase II, investigator-initiated, clinical protocol will be led by Dr. Marilyn Glassberg Csete, Chief of Pulmonary, Critical Care, and Sleep Medicine at the University of Arizona College of Medicine/Banner – University Medical Center Phoenix. The Banner trial will seek to enroll 40 patients with hospitalized COVID-19 patients once authorized by the U.S. FDA.

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 of Silmitasertib. 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 (RPD) in Medulloblastoma by the US FDA. An eIND was granted by the US FDA on August 27, 2020, to Dr. Rayyan for use in the COVID patient treated at BUMCP.