Sipavibart Meets Primary Endpoints in SUPERNOVA Phase III Trial for Long-Acting Prevention of COVID-19 in Immunocompromised Patients

May 21, 2024 10:28 CST Updated 10:28

AstraZeneca

Biopharmaceutical Manufacturer

SUPERNOVA Phase III clinical trial results show,AstraZeneca's sipavibart (formerly known as AZD3152), an investigational long-acting antibody (LAAB), in the immunocompromised patient population, compared with the control group (tixagevimab/cilgavimab or placebo),Significantly reduced the incidence of symptomatic COVID-19。

The trial met two primary endpoints:

Relative Risk Reduction of Symptomatic COVID-19 Caused by Any SARS-CoV-2 Variant
Relative Risk Reduction of Infections Caused by SARS-CoV-2 Variants Without the F456L Mutation

SUPERNOVA demonstrated the potential benefits of sipavibart in an evolving variant landscape, with COVID-19 cases during the trial caused by several different SARS-CoV-2 variants.

SUPERNOVA is a large Phase III global trial,Provided the only efficacy data for immunocompromised patients, demonstrating the potential benefits of COVID-19 antibodies against recent SARS-CoV-2 variants.

Immunocompromised patientsIncluding people with blood cancers, organ transplant recipients, patients with end-stage renal disease requiring dialysis, patients who have received B-cell depleting therapy in the past year, and individuals taking immunosuppressive medications. Despite accounting for approximately 4% of the population, immunocompromised patients stillAccounting for approximately 25% of COVID-19 hospitalizations, ICU admissions, and deaths。

"Sipavibart has the potential to provide much-needed COVID-19 protection for this highly vulnerable population by directly delivering anti-infective antibodies to patients who typically respond poorly to vaccines," said Dr. Ghady Haidar, a transplant infectious diseases physician at UPMC, Medical Director of the Translational Research Program in the UPMC Division of Infectious Diseases, and principal investigator of the SUPERNOVA trial. "COVID-19 still poses a significant and disproportionate risk to immunocompromised patients, with infections often leading to severe and prolonged illness."

AstraZeneca’s Executive Vice President of Vaccines and Immune Therapies, Iskra Reic, stated: "Immunocompromised patients currently have limited or no protection options against COVID-19. Despite typically being fully vaccinated, they still face a significant disease burden. Sipavibart has the potential to prevent COVID-19 in immunocompromised patients, and we will now collaborate with global regulatory authorities to bring sipavibart to these vulnerable patients."

Sipavibart was well tolerated in the trial.Preliminary analysis shows that adverse events were balanced between the control group and the sipavibart group.Data will be presented at an upcoming medical conference

AboutSUPERNOVA

SUPERNOVA is a Phase III, global, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of sipavibart versus control (tixagevimab/cilgavimab or placebo) in preventing COVID-19. The trial was conducted at 197 sites across the United States, the United Kingdom, the European Union, and Asia. Participants were randomly assigned in a 1:1 ratio to receive either 300 mg intramuscular injection of sipavibart or the control, with 1669/3335 participants receiving sipavibart and 1666/3335 participants receiving the control. A second dose of sipavibart or control was administered approximately six months after the initial administration of the study product.

Participants are individuals aged 12 years and above, defined as having an increased risk of inadequate active immune response (predicted poor response to or intolerance of vaccines). At screening, participants tested negative for SARS-CoV-2 serology on-site. Participants will be followed for 15 months, with SARS-CoV-2 neutralizing antibodies assessed at 1 month, 3 months, and 6 months.

All participants had immunocompromised conditions and/or were receiving immunosuppressive therapy, placing them at risk for an inadequate immune response to the vaccine and at high risk for developing severe COVID-19.

About Sipavibart

Sipavibart (formerly known as AZD3152) is an investigational long-acting monoclonal antibody (LAAB) for COVID-19. Sipavibart is designed to neutralize the interaction between the spike protein and the host receptor ACE2.CoverageOmicron and Ancestral Virus Variants.

Sipavibart is derived from B-cell donations of recovered patients post SARS-CoV-2 infection. Sipavibart is engineered using the same antibody framework as Evusheld and optimized with the same half-life extension, reduced Fc effector function, and minimized complement C1q binding platform. The reduction in Fc effector function aims to minimize the risk of antibody-dependent disease enhancement — a phenomenon where virus-specific antibodies promote rather than inhibit infection and/or disease.

Sipavibart was exclusively licensed by AstraZeneca from RQ Biotechnology in May 2022.

Source:

AstraZeneca Official Website

Scan the WeChat QR code to add the editor of the Antibody Circle.Those who meet the requirements can join the Antibody Circle WeChat group!

Please indicate: Name + Research Direction!

All reproduced articles in this official account are intended to convey more information, with the source and author clearly stated. Media or individuals who do not wish to be reproduced can contact us at cbplib@163.com, and we will delete the content immediately. All articles represent the views of the author and do not represent the position of this website.