FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of May 2024
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
SUPERNOVA Trial Met COVID-19 prevention endpoint
16 May 2024
SUPERNOVA Phase III trial of sipavibart long-acting antibody met
primary endpoints in preventing COVID-19 in immunocompromised
patient population
Positive high-level results from the SUPERNOVA Phase III COVID-19
pre-exposure prophylaxis (prevention) trial showed AstraZeneca's
sipavibart (formerly AZD3152), an investigational long-acting
antibody (LAAB), demonstrated a statistically significant reduction
in the incidence of symptomatic COVID-19 compared to control (tixagevimab/cilgavimab or
placebo) in an immunocompromised patient
population.
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. 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.
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, medical
director of the translational research program at UPMC's division
of infectious diseases and SUPERNOVA trial primary investigator,
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, the data support that sipavibart has the potential to
provide much-needed protection against COVID-19 in this highly
vulnerable population."
Iskra Reic, Executive Vice President, Vaccines and Immune
Therapies, AstraZeneca, said: "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 was well tolerated in the trial and preliminary analyses
show adverse events were balanced between the control and
sipavibart arms.
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,
placebo-controlled trial assessing the safety and efficacy of
sipavibart compared to control (tixagevimab/cilgavimab or placebo)
for the prevention of COVID-19. 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. The first evaluated
the efficacy of sipavibart against any confirmed SARS-CoV-2
positive symptomatic illness occurring post dose prior to day 181
caused by any variant (i.e., all cases regardless of if the variant
has the F456L mutation or not, which sipavibart is not expected to
neutralise). The second dual primary efficacy analysis was
conducted using only the confirmed COVID-19 cases in the trial
where the variant causing the COVID-19 cases did not have the F456L
mutation, referred to as a "matched" variant analysis.
Participants were individuals 12 years of age and over who would
benefit from prevention with the investigational LAAB, defined as
having increased risk for inadequate response to active
immunisation (predicted poor responders to vaccines or intolerant
of vaccine). 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, which put them at risk
to mount an inadequate immune response to vaccination and at high
risk of developing severe COVID-19. 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 was
designed to provide broad and potent coverage across Omicron and
ancestral viral variants by neutralising spike protein interaction
with the host receptor ACE2.7
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 and was optimised with the same half-life
extension and reduced Fc effector function and complement C1q
binding platform.7 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.
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 astrazeneca.com and
follow the Company on Social Media @AstraZeneca.
Contacts
For details on how to contact the Investor
Relations Team, please click here.
For Media contacts, click here.
References
1. Evans RA et al. Impact of COVID-19
on Immunocompromised Populations during the Omicron Era: Insights
from the Observational Population-Based INFORM
Study. The Lancet Regional Health -
Europe. 2023;0(0):100747.
doi:10.1016/J.LANEPE.2023.100747
2.
Dube S. Continued Increased Risk of COVID-19 Hospitalisation and
Death in Immunocompromised Individuals Despite Receipt of ≥4
Vaccine Doses: Updated 2023 Results from INFORM, a Retrospective
Health Database Study in England. Poster P0409 at ECCMID
2024.
3.
Turtle L. Individuals with Multiple Sclerosis Are at High Risk for
COVID-19 Hospitalisation and Death Despite High Rates of
Vaccination: Results from the England INFORM Study. Oral
Presentation at ECCMID 2024.
4.
Meeraus W. High Prevalence of Immunocompromising Conditions Among
Patients with Severe Acute Respiratory Infection, Including
SARS-CoV-2: Results from a Multicentre, Test-Negative Case Control
Study. Abstract #01796 at ECCMID 2024.
5.
Meeraus W. Immunocompromise, Cancer and Other Comorbidities in
Patients with Severe Acute Respiratory Infection Testing Positive
Versus Negative for SARS-CoV-2: A Post Hoc Analysis of COVIDRIVE
Data from May 2021 to May 2023. Abstract #01800 at ECCMID
2024.
6. Ketkar A et al. Assessing the Risk
and Costs of COVID-19 in Immunocompromised Populations in a Large
United States Commercial Insurance Health Plan: The EPOCH-US
Study. Curr Med Res Opin.
2023. 39
(8):1103-1118.
7. Francica JR, Cai Y, Diallo S, et
al. 1355. The SARS-CoV-2 Monoclonal Antibody AZD3152 Potently
Neutralizes Historical and Emerging Variants and is Being Developed
for the Prevention and Treatment of COVID-19 in High-risk
Individuals. Open Forum Infect
Dis. 2023 Nov 27;10(Suppl
2):ofad500.1192. doi:
10.1093/ofid/ofad500.1192.
Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
16 May 2024
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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