Clinical Trials

The investigational long-acting antibody (LAAB) demonstrated a statistically significant reduction in the incidence of symptomatic COVID-19 compared to a control group being treated with tixagevimab/cilgavimab or placebo, in an immunocompromised patient population.

The trial met both dual primary endpoints, the first being the relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant, and the second being the relative risk reduction of infections caused by SARS-CoV-2 variants not containing the F456L mutation.

Iskra Reic, executive vice president of vaccines and immune therapies at AstraZeneca, commented: “Immunocompromised patients currently have limited or no options for COVID-19 protection and continue to face a significant burden of disease, despite often being fully vaccinated. Sipavibart has the potential to prevent COVID-19 in the immunocompromised and we will now work with regulatory authorities globally to bring sipavibart to these vulnerable patients.”

Ghady Haidar MD, Universit y of Pittsburgh Medical Center (UMPC), US, transplant infectious diseases physician, medical director of the translational research programme at UPMC’s division of infectious diseases and SUPERNOVA trial primary investigator, added: “COVID-19 still represents a significant and disproportionate risk for immunocompromised patients, with infection often leading to serious and protracted illness. By delivering infection-fighting antibodies directly to patients who often don’t respond adequately to vaccines, the data support that sipavibart has the potential to prov ide much-needed protection against COVID-19 in this highly vulnerable population.”

The data is expected to be presented at an upcoming medical meeting, and the company is already in conversation with the relevant regulatory authorities around potential authorisation or approva l pathways.