sipavibart长效抗体的SUPERNOVA III期试验达到了预防免疫功能低下患者COVID-19的主要终点

SUPERNOVA III期COVID-19暴露前预防(prevention)试验的阳性高水平结果显示，澳门在线赌城娱乐(AstraZeneca)的sipavibart(原AZD3152), an investigational long-acting antibody (LAAB), 在免疫功能低下患者群体中，与对照组(替沙吉维单抗/西加维单抗或安慰剂)相比，症状性COVID - 19的发生率有统计学显著降低.

The trial met both dual primary endpoints; the first one being the relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant and the second being the relative risk reduction of infections caused by SARS-CoV-2 variants not containing the F456L mutation. 在不断变化的变异环境中，在试验过程中捕获的COVID-19病例是由几种不同的SARS-CoV-2变异引起的，SUPERNOVA证明了sipavibart的潜在益处.

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. Immunocompromised patients include those with blood cancer, organ transplant recipients, patients with end-stage renal disease requiring dialysis, patients receiving B-cell depleting therapy within the past year, and those taking immunosuppressive medications. Despite accounting for approximately 4% of the population, immunocompromised patients make up about 25% of COVID-19 hospitalisations, ICU admissions, and deaths, even after multiple doses of COVID-19 vaccines.^1-6

Ghady Haidar, M.D., UPMC (University of Pittsburgh Medical Center) transplant infectious diseases physician, UPMC传染病部转化研究项目的医学主任和SUPERNOVA试验的主要研究者, said: “COVID-19 still represents a significant and disproportionate risk for immunocompromised patients, with infection often leading to serious and protracted illness. By delivering infection-fighting antibodies directly to patients who often don’t respond adequately to vaccines, 数据支持sipavibart有潜力为这一高度脆弱的人群提供急需的COVID-19保护.”

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, 他说:“免疫功能低下的患者目前没有或只有有限的COVID-19保护选择，并继续面临重大的疾病负担, despite often being fully vaccinated. Sipavibart有可能在免疫功能低下的患者中预防COVID-19，澳门第一赌城在线娱乐现在将与全球监管机构合作，将Sipavibart带给这些弱势患者.”

Sipavibart在试验中耐受性良好，初步分析显示对照组和Sipavibart组的不良事件是平衡的.

The data will be presented at a forthcoming medical meeting. AstraZeneca is in dialogue with regulatory authorities on potential authorisation or approval pathways.

Notes

SUPERNOVA
SUPERNOVA is a Phase III, global, randomised, double-blind, 与对照组(替沙吉维单抗/西加维单抗或安慰剂)相比，评估西帕韦巴特预防COVID-19的安全性和有效性的安慰剂对照试验. The trial was conducted at 197 sites in the US, UK, EU and Asia. Participants were randomised in a 1:1 ratio to receive either a 300mg intramuscular dose of sipavibart or comparator, with 1,669/3,335 participants receiving sipavibart and 1,666/3,335 receiving comparator. A second dose of sipavibart or comparator was given approximately six months after initial receipt of study product.

The trial had dual primary efficacy endpoints. 第一项研究评估了西帕巴特对181天之前在给药后发生的由任何变异(i.e., all cases regardless of if the variant has the F456L mutation or not, which sipavibart is not expected to neutralise). 第二次双主要疗效分析仅使用试验中确诊的COVID-19病例，其中导致COVID-19病例的变异不存在F456L突变, referred to as a “matched” variant analysis.

参与者是12岁及以上的个体，他们将受益于研究性LAAB的预防, 定义为对主动免疫反应不足的风险增加(预测对疫苗反应不良或对疫苗不耐受). Participants at the time of screening had a negative point-of-care SARS-CoV-2 serology test. Participants will be followed for 15 months, with SARS-CoV-2 neutralising antibodies assessed at one, three and six months.

All participants in the trial had an immunocompromising condition and/or were on immunosuppressive treatments, 这使他们面临对疫苗接种产生不充分免疫反应的风险，并面临发展为严重COVID-19的高风险. This included patients with 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, among others. Across the treatment groups, demographic and baseline characteristics were generally well balanced.

Sipavibart
Sipavibart (formerly AZD3152) is an investigational long-acting monoclonal antibody (LAAB) against COVID-19. Sipavibart旨在通过中和刺突蛋白与宿主受体ACE2的相互作用，在Omicron和祖先病毒变体中提供广泛而有效的覆盖.⁷

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 优化后具有相同的半衰期延长，降低了Fc效应函数和补体C1q结合平台.⁷ 减少Fc效应功能的目的是尽量减少抗体依赖性疾病增强的风险——病毒特异性抗体促进疾病增强的一种现象, rather than inhibit, infection and/or disease.

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

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit sh-fyz.com and follow the Company on Social Media @AstraZeneca.

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References

Adrian Kemp
Company Secretary
AstraZeneca PLC