AstraZenecas sipavibart shown to prevent COVID-19 in immunocompromised patients – PMLiVE

AstraZeneca (AZ) has shared positive results from a late-stage study evaluating the efficacy of its investigational long-acting monoclonal antibody, sipavibart, in preventing COVID-19 in immunocompromised individuals.

Despite accounting for approximately 4% of the population, immunocompromised patients make up about 25% of COVID-19 hospitalisations, intensive care unit admissions and deaths.

The phase 3 SUPERNOVA trial has been comparing sipavibart, formerly AZD3152, to tixagevimab/cilgavimab or placebo in patients aged 12 years and older who are at an increased risk of mounting an inadequate response to active immunisation and at a high risk of developing severe COVID-19.

This included solid organ transplant recipients, patients with haematologic malignancies or end-stage kidney disease, and those within one year of receiving B cell depleting therapy, with AZ noting that demographic and baseline characteristics across the treatment groups were generally well balanced.

The study met its dual primary endpoints of relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant and relative risk reduction of infections caused by SARS-CoV-2 variants not containing the F456L mutation.

Sipavibart was also shown to be well tolerated and preliminary analyses demonstrated that adverse events were balanced between the control and sipavibart arms.

By delivering infection-fighting antibodies directly to patients who often dont respond adequately to vaccines, the data supports that sipavibart has the potential to provide much-needed protection against COVID-19 in this highly vulnerable population, said SUPERNOVA trial primary investigator Ghady Haidar, University of Pittsburgh Medical Center.

AZ outlined that the data will be presented at a forthcoming medical meeting, adding that it is in dialogue with regulatory authorities on potential authorisation or approval pathways.

Iskra Reic, executive vice president, vaccines and immune therapies, AZ, said: 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.

The readout comes just one week after AZ said it had begun the global withdrawal of its COVID-19 vaccine, citing a surplus of vaccines that have been updated to target new variants of the virus.

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AstraZenecas sipavibart shown to prevent COVID-19 in immunocompromised patients - PMLiVE