AstraZeneca prepares fresh COVID push to regulators after antibody's phase 3 success

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来源: FierceBiotech

AstraZeneca said its study “demonstrated the potential benefit of sipavibart in an evolving variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants.”

While AstraZeneca’s globally used COVID-19 vaccineCOVID-19 vaccine is leaving the scene, the British Big Pharma is hoping it will be taking a fresh therapeutic option to regulators soon.

Results from the phase 3 SUPERNOVA study show that the company’s investigational long-acting antibody (LAA) sipavibart produced a statistically significant reduction in the incidence of symptomatic COVID‑19.

The global trial of 3,335 immunocompromised patients saw half receive a 300-mg intramuscular dose of sipavibart and the others receive either AstraZeneca’s previously authorized LAA combo COVID-19 treatment Evusheld or placebo.

The study had two primary endpoints: reducing the number of cases of COVID-19 caused by any variant of the virus and the relative risk reduction of infections caused by variants not containing the F456L mutation. SUPERNOVA hit both these goals, said AstraZeneca, although it didn’t provide any details of the data.

Still, the Big Pharma said the study had “demonstrated the potential benefit of sipavibart in an evolving variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants.”

The participants involved were aged 12 years and over and included patients with blood cancer, organ transplant recipients, patients with end-stage renal disease requiring dialysis, those receiving B-cell depleting therapy within the past year and people taking immunosuppressive medications.

“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,” AstraZeneca’s executive vice president of vaccines and immune therapies Iskra Reic said in the release.

“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,” Reic added.

Sipavibart was derived from B cells donated by convalescent patients who had previously been infected with COVID-19. The treatment is engineered using the same antibody scaffold as Evusheld. The FDA rescinded its authorization of Evusheld in January 2023 when it became clear it was ineffective against some of the newer variants of COVID-19.

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