AstraZeneca plans new COVID push post antibody's phase 3 success

AstraZeneca's recent phase 3 SUPERNOVA study highlights promising results for its investigational long-acting antibody (LAA), sipavibart, in combating COVID-19. The British pharmaceutical giant is optimistic that sipavibart will soon gain regulatory approval as a new therapeutic option, especially as its widely used COVID-19 vaccine is being phased out.

The SUPERNOVA trial involved 3,335 immunocompromised participants, who were split into two groups. One group received a 300-mg intramuscular dose of sipavibart, while the other was given either AstraZeneca’s previously approved LAA combo COVID-19 treatment Evusheld or a placebo. These participants, aged 12 years and above, included individuals with blood cancers, organ transplant recipients, patients undergoing dialysis for end-stage renal disease, those who had received B-cell depleting therapy within the past year, and people on immunosuppressive medications.

The study had dual primary goals: reducing the incidence of COVID-19 caused by any variant of the virus and minimizing the relative risk of infections from variants not containing the F456L mutation. AstraZeneca announced that the study met both objectives, although specific data details were not disclosed. The company emphasized the study's significance, stating that it illustrated sipavibart’s potential benefits in a continually evolving variant landscape where multiple SARS-CoV-2 variants were responsible for COVID-19 cases during the trial.

Iskra Reic, AstraZeneca’s executive vice president of vaccines and immune therapies, highlighted the critical need for effective COVID-19 protection among immunocompromised patients. These patients, despite often being fully vaccinated, still face considerable risks and have limited options for COVID-19 protection. Reic emphasized that sipavibart could address this gap and stated that AstraZeneca would collaborate with global regulatory authorities to make sipavibart available to these vulnerable groups.

Sipavibart is derived from B cells donated by patients who previously recovered from COVID-19. The treatment utilizes the same antibody framework as Evusheld. It's noteworthy that the FDA withdrew Evusheld's authorization in January 2023 after it was found to be ineffective against some newer COVID-19 variants.

In conclusion, AstraZeneca's phase 3 SUPERNOVA study marks a significant step towards providing enhanced protection for immunocompromised individuals against COVID-19. By demonstrating sipavibart's efficacy in reducing symptomatic COVID-19 cases across various SARS-CoV-2 variants, AstraZeneca aims to secure regulatory approval and offer a new, crucial therapeutic option for these high-risk patients.