Sipavibart is an investigational long-acting antibody designed to provide COVID-19 protection for immunocompromised patients
The
The MAA is based on positive results from the SUPERNOVA Phase III trial which demonstrated sipavibart's safety and efficacy in preventing symptomatic COVID-19 in immunocompromised patients, compared to control, in a variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants.1 SUPERNOVA is the only Phase III trial that provides efficacy data for COVID-19 pre-exposure prophylaxis exclusively in immunocompromised patients.2
Prof.
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies,
Data from the SUPERNOVA trial will be presented at a forthcoming medical meeting.
In addition to the EMA,
Notes
COVID-19 and the continued unmet need in the immunocompromised population
Despite the
SUPERNOVA
SUPERNOVA is a large Phase III, global, randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of sipavibart compared to control (tixagevimab/cilgavimab or placebo) for the prevention of COVID-19, providing the only COVID-19 efficacy data in immunocompromised patients.2
Positive high-level results from SUPERNOVA showed that sipavibart demonstrated a statistically significant reduction in the incidence of symptomatic COVID-19 compared to control (tixagevimab/cilgavimab or placebo) in an immunocompromised patient population.1 The trial met both dual primary endpoints; 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 not containing the F456L mutation.1 SUPERNOVA 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.1
All participants in the trial had an immunocompromising condition and/or were on immunosuppressive treatments, which put them at risk to mount an inadequate immune response to vaccination and at high risk of developing severe COVID-19. Participants enrolled in the study included patients with conditions such as hematologic malignancies, solid organ transplant recipients, hematopoietic stem cell transplants, end stage kidney disease/dialysis, and being within one year of receipt of B cell depleting therapy.
Sipavibart was generally well-tolerated in the trial and preliminary analyses show adverse events were balanced between the control and sipavibart arms.1
Sipavibart
Sipavibart (formerly AZD3152) is an investigational long-acting monoclonal antibody (LAAB) against COVID-19. Sipavibart was designed to provide broad and potent coverage across Omicron and ancestral viral variants by neutralising spike protein interaction with the host receptor ACE2.9
Sipavibart was derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. Sipavibart has been engineered using the same antibody scaffold as Evusheld and was optimised with the same half-life extension and reduced Fc effector function and complement C1q binding platform.9 The reduced Fc effector function aims to minimise the risk of antibody-dependent enhancement of disease - a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.
Contact:
Email: global-mediateam@astrazeneca.com
Tel: +44 (0)1223 344 800
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