REG - AstraZeneca PLC - SUPERNOVA Trial Met COVID-19 prevention endpoint

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16/05/2024 07:00

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RNS Number : 6255O  AstraZeneca PLC  16 May 2024

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
(https://www.astrazeneca.com/media-centre/press-releases/2022/astrazeneca-signs-licence-agreement-with-rq-biotechnology-for-monoclonal-antibodies-against-covid-19.html)
.

 

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 (http://www.astrazeneca.com/) and follow the
Company on Social Media @AstraZeneca (https://twitter.com/AstraZeneca) .

 

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

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

 

 

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