AstraZeneca’s Investigational COVID-19 Prevention Drug Reduces Risk of Infection in Immunocompromised Persons

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Sipavibart, an investigational long-acting antibody (LAAB) manufactured by AstraZeneca, was associated with a statistically significant reduction in the incidence of symptomatic COVID-19 compared to control treatments in immunocompromised patients, according to the company.

In a statement released today, AstraZeneca announced positive high-level findings from the SUPERNOVA phase 3 trial examining the safety and efficacy of sipavibart (formerly AZD3152) compared to controls (tixagevimab/cilgavimab or placebo) for the prevention of COVID-19. The trial is the first to provide efficacy data in immunocompromised individuals, the manufacturer noted.

“COVID-19 still represents a significant and disproportionate risk for immunocompromised patients, with infection often leading to serious and protracted illness,” Ghady Haidar, MD, SUPERNOVA primary investigator, medical director, translational research program, Division of Infectious Diseases, University of Pittsburgh Medical Center, said in the release. “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 provide much-needed protection against COVID-19 in this highly vulnerable population.”

Sipavibart was designed for broad, potent coverage across Omicron and ancestral viral variants by neutralizing spike protein interaction with the host receptor ACE2.7, according to the May 16, 2024, press release.

SUPERNOVA met its dual primary endpoints: the relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant and the relative risk reduction of infections caused by SARS-CoV-2 variants that did not contain the F456L mutation, which sipavibart is not expected to neutralize.

The study was conducted at 197 sites across the US, UK, EU, and Asia. All participants had an immunocompromising condition and/or were receiving immunosuppressive treatments. This included those with hematologic malignancies, those with end-stage renal disease requiring dialysis, and those receiving B-cell depleting therapy within the past year.

A total of 3335 participants aged 12 years and older were randomly assigned in a 1:1 ratio to receive either an intramuscular dose of sipavibart 300 mg (n=1669) or tixagevimab/cilgavimab or placebo (n=1666). Participants received an additional dose of sipavibart or control approximately 6 months after receiving the first dose.

At the time of screening, participants had a negative point-of-care SARS-CoV-2 serology test. They will be followed for 15 months and researchers will assess SARS-CoV-2 neutralizing antibodies at 1, 3, and 6 months, according to AstraZeneca.

“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,” Iskra Reic, executive vice president, Vaccines and Immune Therapies, AstraZeneca, 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.”

The company added that findings from SUPERNOVA will be presented at an upcoming medical meeting, although they did not specify which one. They are also speaking with regulatory authorities about potential authorization or approval pathways.

Reference: SUPERNOVA phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19 in immunocompromised patient population. News release. AstraZeneca. May 16, 2024. Accessed May 16, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/supernova-trial-met-covid-19-prevention-endpoint.html