Senhwa Announces First Patient Enrolled in Silmitasertib Trial for Severe COVID-19

Senhwa Biosciences announced that the first patient has enrolled into an investigator-initiated trial (IIT) of its investigational drug, Silmitasertib, as a treatment for hospitalized COVID-19 patients at Banner Health-University Medical Center in Phoenix, Arizona (BUMCP).

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.

"Silmitasertib's mechanism of action by CK2 inhibition is a unique pathway to target a SARS-CoV-2 infection which is a promising approach to combating COVID-19," said Dr. Marilyn Glassberg Csete, the Principle Investigator of this BUMCP IIT trial. The study's objectives are to assess Silmitasertib's safety and tolerability as well as time to recovery and clinical benefits for the patients treated with Silmitasertib.

"We were encouraged by the quick recovery (discharged from hospital in 5 days) of the first hospitalized patient with severe COVID-19 who received Silmitasertib under an emergency IND with Dr. Esa Rayyan. Now, with the remarkable job done on this IIT trial by Dr. Glassberg Csete's team, we hope this trial will also demonstrate the clinical benefits of Silmitasertib for hospitalized patients," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

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 (CARE) in Gainesville, Georgia. Dr. Recknor's trial enrolled their first patient on December 3, 2020.