SUPERNOVA Study Shows Long-acting Antibody Prevents COVID-19 in Immunocompromised People

During the early stages of the recent pandemic, AstraZeneca's Evusheld antibody was an effective therapeutic option. However, as the SARS-CoV coronavirus evolved, the U.S. FDA withdrew Evusheld's authorization in early 2023.

According to the company's press release on May 16, 2024, positive high-level results from the SUPERNOVA Phase III COVID-19 pre-exposure prophylaxis (prevention) trial showed sipavibart (AZD3152), an investigational long-acting antibody (LAAB), demonstrated a statistically significant reduction in the incidence of symptomatic COVID‑19 compared to control in an immunocompromised patient population.

SUPERNOVA is a large Phase III global trial providing the only efficacy data in immunocompromised patients, demonstrating the potential benefit of a COVID-19 antibody against recent SARS-CoV-2 variants.

Sipavibart was well tolerated in the trial, and preliminary analyses showed that adverse events were balanced between the control and sipavibart arms.

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, 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."

Sipavibart is not a preventive vaccine.

It was engineered using the same antibody scaffold as Evusheld and optimized with the same half-life extension, reduced Fc effector function, and complemented the C1q binding platform.

The reduced Fc effector function aims to minimize the risk of antibody-dependent disease enhancement - a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.

According to the press release, AstraZeneca is in dialogue with regulatory authorities on potential authorization or approval pathways.