Encouraging top-line results from the SUPERNOVA Phase III trial for COVID-19 pre-exposure prophylaxis revealed that AstraZeneca's investigational long-acting antibody, sipavibart (previously known as AZD3152), significantly reduced the occurrences of symptomatic COVID-19 in comparison to the control group (either tixagevimab/cilgavimab or placebo) within an immunocompromised cohort.
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The trial achieved success in both of its primary objectives: the first being the reduction in relative risk of symptomatic COVID-19 caused by any SARS-CoV-2 variant, and the second being the reduction in relative risk of infections by SARS-CoV-2 variants lacking the F456L mutation. The SUPERNOVA study illustrated the potential advantages of sipavibart in a landscape of evolving variants, with COVID-19 cases observed during the trial attributed to multiple different SARS-CoV-2 variants.
SUPERNOVA is an extensive Phase III international trial that provides unique efficacy data for immunocompromised patients, showcasing the potential benefits of a COVID-19 antibody against recent SARS-CoV-2 variants. Immunocompromised individuals include those with hematological cancers, organ transplant recipients, patients with end-stage renal disease on dialysis, individuals who have received B-cell depleting therapy in the past year, and those on immunosuppressive drugs.
Although immunocompromised patients make up around 4% of the population, they account for approximately 25% of COVID-19 hospitalizations, ICU admissions, and deaths, even after receiving multiple doses of COVID-19 vaccines.
Ghady Haidar, M.D., a UPMC transplant infectious diseases physician and primary investigator for the SUPERNOVA trial, stated: “COVID-19 still poses a significant and disproportionate risk to immunocompromised patients, often leading to severe and prolonged illness. By administering infection-fighting antibodies directly to patients who frequently have inadequate responses to vaccines, the data indicate that sipavibart could provide critical protection against COVID-19 for this highly susceptible group.”
Iskra Reic, Executive Vice President of Vaccines and Immune Therapies at AstraZeneca, added: “Immunocompromised patients currently have few or no options for COVID-19 protection and continue to bear a significant disease burden despite often being fully vaccinated. Sipavibart has the potential to prevent COVID-19 in the immunocompromised, and we will now collaborate with regulatory authorities worldwide to make sipavibart available to these vulnerable individuals.”
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According to the data provided by the Synapse Database, As of May 23, 2024, there are 484 investigational drugs for the SARS-CoV-2 S protein targets, including 44 indications, 449 R&D institutions involved, with related clinical trials reaching 993, and as many as 1144 patents.
Sipavibart is a monoclonal antibody drug developed by AstraZeneca PLC, targeting the SARS-CoV-2 S protein for the treatment of COVID-19. With its focus on Infectious Diseases and Respiratory Diseases, the drug has reached the Phase 2/3 stage of clinical development, signifying its advancement in the evaluation process. As the global community continues to seek effective solutions for the COVID-19 pandemic, the progress of Sipavibart represents a significant development in the field of biomedicine.