Companies are designing a new type of antibodies, modelled on those found in people whose immune system can naturally neutralize any COVID-19 variant.
Super-antibodies are a new generation of highly potent and broadly cross-reactive human monoclonal antibodies. These types of antibodies are naturally produced by the body, but only on rare occasions, as a response to infections.
Now, scientists have engineered a super-antibody called sotrovimab and on May 26 of this year, the U.S. Food and Drug Administration (FDA) authorised the use of this monoclonal antibody (mAb) therapy for mild-to-moderate COVID-19 in adults and paediatric patients (12 years of age and older), under their emergency use authorization scheme.
“With the authorization of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in a FDA press release.
The hope is that this new treatment may retain effective activity against all current variants of COVID-19.
What exactly is sotrovimab?
Super-antibodies are a type of monoclonal antibodies, lab-made proteins that seek to replicate the immune system’s ability to fight off dangerous agents, such as viruses. Sotrovimab is a monoclonal antibody that has been engineered to target the spike protein of SARS-CoV-2, with the goal of blocking the virus’ ability to attach and enter into human cells.
Data supporting this new drug comes from a phase 1/2/3 randomized, double-blind, placebo-controlled clinical trial, involving 583 non-hospitalized adults who carried the COVID-19 virus and had mild-moderate symptoms. Among these patients, it was shown that hospitalization or death among those receiving sotrovimab occurred in 1% (3 individuals) of patients, compared to 21 (7%) among patients receiving placebo only. Some possible side effects of sotrovimab include anaphylaxis and infusion-related reactions, rash and diarrhea.
In Australia, the Therapeutic Goods Administration (TGA) has granted provisional determination to GlaxoSmithKline Australia Pty Ltd (GSK) in relation to sotrovimab and has received GSK’s application for provisional registration of this drug. The TGA is currently evaluating the data backing the use of sotrovimab.