Clinical-stage biopharmaceutical company Senhwa Biosciences has enrolled the first patient in a Phase II trial of its investigational drug, Silmitasertib, for treating hospitalised Covid-19 patients.
An oral medication, Silmitasertib targets the host protein kinase CK2, where virus mutations might not affect its anti-viral and anti-inflammatory efficacy.
Senhwa noted that Silmitasertib challenges the ability of the virus to replicate faster and spread to adjacent healthy cells.
The patient has been enrolled at Banner Health-University Medical Center in Phoenix (BUMCP), Arizona, US.
BUMCP IIT trial principal investigator Dr Marilyn Glassberg Csete said: “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.”
The multi-centre, open-label, randomised, controlled interventional prospective, investigator-initiated trial (IIT) study plans to enrol 40 patients with severe Covid-19. Half of patients will be given Silmitasertib for a period of 14 days.
Evaluating the drug’s safety and tolerability, as well as time to recovery and clinical benefits for the participants receiving the treatment, will be the trial’s objective.
Senhwa Biosciences chief medical officer Dr John Soong said: “We were encouraged by the quick recovery (discharged from hospital in five days) of the first hospitalised 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 hospitalised patients.”
The company noted that another Phase II IIT for outpatient adult participants with moderate Covid-19 is currently progressing in the Center for Advanced Research and Education (CARE) in Gainesville, Georgia. Dr Recknor’s trial had enrolled the first patient last month.