Clinical-stage biopharma firm Senhwa Biosciences has enrolled the first patient in a Phase II investigator-initiated trial (IIT) of its anti-SARS-CoV-2 investigational drug, Silmitasertib, for treating Covid-19.
The patient with moderate Covid-19 was enrolled at the Center for Advanced Research and Education (CARE) in Gainesville, Georgia.
A small-molecule oral drug, Silmitasertib targets the host protein kinase casein kinase 2 (CK2) pathway, where virus mutations might not affect its anti-viral and anti-inflammatory efficacy.
It challenges the virus’ ability to replicate rapidly and spread to other healthy cells.
In August, the CK2-inhibitor received an eIND from the US Food and Drug Administration (FDA) to treat a patient with severe Covid-19.
The first hospitalised patient with severe disease, treated under an eIND was discharged in five days after receiving Silmitasertib, Senhwa noted.
Principal investigator of the trial Dr Chris Recknor said: “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.”
The single-centre, open-label, randomised-controlled interventional prospective study will have 20 patients with moderate Covid-19 and half of them will be given Silmitasertib for 14 days.
Evaluating the safety and tolerability of the drug, recovery time of the patient and possible clinical benefits of treatment with Silmitasertib are the trial’s objectives.
Senhwa Biosciences chief medical officer Dr John Soong said: “We are encouraged by the quick recovery of the first hospitalised 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.”
Apart from this, a Phase II IIT led by Dr Marilyn Glassberg Csete at Banner – University Medical Center Phoenix is set to start as FDA has given nod.
The trial plans to enrol around 40 hospitalised patients with severe Covid-19.