Senhwa Enrolls First Patient in Silmitasertib Trial for COVID-19

Senhwa Biosciences announced the first patient was enrolled into a Phase II investigator-initiated trial (IIT) of its anti-SARS-CoV-2 investigational drug, Silmitasertib, as a treatment for coronavirus disease (COVID-19) at the Center for Advanced Research and Education (CARE) in Gainesville, Georgia.

This IIT is a phase II single-center, open-label, randomized-controlled interventional prospective study. It is designed to enroll 20 patients with moderate COVID-19, where half will receive Silmitasertib for 14 days. The study's objectives are to assess the safety and tolerability of the drug product, recovery time of the patient, and possible clinical benefits of treatment with Silmitasertib.

"We are encouraged by the quick recovery of the first hospitalized patient with severe COVID-19 who received Silmitasertib under an emergency IND. We also believe Silmitasertib has the potential to be an effective outpatient treatment for patients with moderate COVID-19," said Dr. John Soong, Chief Medical Officer of Senhwa Biosciences.

Senhwa's Silmitasertib is an oral medication, targeting the host protein kinase CK2 (casein kinase 2) pathway, where virus mutations are unlikely to affect its anti-viral and anti-inflammatory efficacy. It 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 SARS-CoV-2 infection which has promise to combat COVID-19," said Dr. Chris Recknor, Principal Investigator of this IIT trial.

A separate Phase II IIT led by Dr. Marilyn Glassberg Csete at Banner – University Medical Center Phoenix is to be initiated as FDA has granted study may proceed letter to Banner on November 26, 2020. The Banner trial will seek to enroll 40 hospitalized patients with severe COVID-19.

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 U.S. FDA for the treatment of Cholangiocarcinoma. In July 2020, Silmitasertib was granted Rare Pediatric Disease Designation (RPD) to treat Medulloblastoma by the U.S. FDA. An eIND was granted by the U.S. FDA on August 27, 2020, to Dr. Rayyan at BUMCP to treat a patient with severe COVID-19.