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 2025
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Breztri met primary endpoints in Ph3 asthma trials
02 May 2025
Breztri met primary endpoints in KALOS and LOGOS
Phase III trials in asthma
Positive high-level results from the Phase III KALOS and LOGOS
trials in patients with uncontrolled asthma showed that
AstraZeneca's fixed-dose triple-combination
therapy Breztri
Aerosphere (budesonide/glycopyrronium/formoterol
fumarate or BGF (320/28.8/9.6lg)) met all primary endpoints,
demonstrating a statistically significant and clinically meaningful
improvement in lung function compared with dual-combination inhaled
corticosteroid/long-acting beta2-agonist (ICS/LABA)
medicines.
KALOS and LOGOS were replicate, randomised, double-blind trials
designed to investigate Breztri as a potential treatment for
asthma.1,2 The
trials evaluated the efficacy and safety
of Breztri versus
maintenance treatment with ICS/LABA in adults and adolescents with
uncontrolled asthma.1,2
Asthma is a common, chronic respiratory disease characterised by
inflammation and muscle tightening in the airway
(bronchoconstriction), which can make it difficult to
breathe.3 As
many as 262 million people worldwide are affected by
asthma,3 and
it is estimated that nearly half of those treated with dual therapy
remain uncontrolled, which can significantly limit lung function
and decrease quality of life.4,5
Alberto Papi, Professor and Chair of Respiratory Medicine at the
University of Ferrara, and Director of the Respiratory Unit,
CardioRespiratory Department, S. Anna University Hospital, Ferrara,
Italy, and primary investigator, said: "Despite advancements in
asthma treatments, millions of patients remain uncontrolled, which
can cause frequent breathlessness, coughing and wheezing,
significantly impacting their ability to perform daily activities.
The results from the KALOS and LOGOS trials are exciting and
demonstrate the potential of budesonide/glycopyrronium/formoterol
to evolve the standard of care to more effectively treat asthma in
a single inhaled triple therapy for patients who remain
uncontrolled with dual maintenance therapy."
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D,
AstraZeneca, said: "We are excited by the positive results from the
KALOS and LOGOS trials, which demonstrate
that Breztri could help improve the lives of the millions
of patients living with asthma. These asthma data build on the
well-established profile of Breztri in COPD, and we look forward to sharing with
regulatory authorities to bring this important medicine to a wider
group of patients."
There were no new safety or tolerability signals identified
for Breztri in KALOS or LOGOS.
Full results from the two Phase III trials will be shared with
regulatory authorities and presented at an upcoming medical
meeting.
Breztri is an inhaled
triple-combination therapy approved for the treatment of chronic
obstructive pulmonary disease (COPD) in adults in more than 80
countries worldwide including the US, EU, China and
Japan.
Notes
Asthma
Asthma is a prevalent, chronic respiratory disease affecting as
many as 262 million people worldwide,3 including
over 25 million in the US.6 When
uncontrolled, inflammation and muscle tightening in the airway
(bronchoconstriction) may cause wheezing, breathlessness, chest
tightness, coughing, and even death.3,7 Many
patients remain uncontrolled despite the availability of standard
of care medicines and continue to experience significant
limitations on lung function and reduced quality of
life.4,5
KALOS and LOGOS Phase III trials
KALOS and LOGOS are replicate confirmatory, randomised,
double-blind, double-dummy, parallel group, multi-centre,
24-to-52-week variable length Phase III trials to assess the
efficacy and safety of BGF (320/28.8/9.6lg and 320/14.4/9.6lg)
compared with two fixed-dose, dual-combination therapies of
budesonide, an ICS, and formoterol fumarate, a LABA: PT009 (in
an Aerosphere inhaler) and Symbicort pressurised metered-dose inhaler
(pMDI).1,2 KALOS
and LOGOS included approximately 4,400 randomised
patients.
The trial design was optimised to evaluate the 320/28.8/9.6lg dose
of BGF. The primary efficacy endpoints for the two individual
trials were a change from baseline in forced expiratory volume in 1
second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
and trough FEV1 over 12-24 weeks and over 24
weeks.1,2
In addition to the two registrational trials (KALOS and LOGOS), two
qualifying trials, LITHOS and VATHOS, also met their primary
endpoints.8,9 LITHOS
and VATHOS included approximately 1,000 randomised
patients.
Breztri/Trixeo Aerosphere
Budesonide/glycopyrronium/formoterol fumarate (BGF), approved under
the brand name Breztri
Aerosphere in Japan, China
and the US, and Trixeo
Aerosphere in the EU, is a
single-inhaler, fixed-dose triple-combination of formoterol
fumarate, a LABA, glycopyrronium bromide, a long-acting muscarinic
antagonist (LAMA), with budesonide, an ICS, and delivered via
the Aerosphere pMDI. Breztri/Trixeo
Aerosphere is approved to
treat adults with COPD in more than 80 countries worldwide
including the US, EU, China, Japan, and was prescribed to more
than 5.5 million patients globally in 2024.10
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca
BioPharmaceuticals, is a key disease area and growth driver to the
Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage and a growing portfolio of medicines in
immune-mediated diseases. The Company is committed to addressing
the vast unmet needs of these chronic, often debilitating, diseases
with a pipeline and portfolio of inhaled medicines, biologics and
new modalities aimed at previously unreachable biologic targets.
Our ambition is to deliver life-changing medicines that help
eliminate COPD as a leading cause of death, eliminate asthma
attacks and achieve clinical remission in immune-mediated
diseases.
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's innovative
medicines are sold in more than 125 countries and 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. Clinicaltrials.gov. Study to Assess
PT010 in Adult and Adolescent Participants with Inadequately
Controlled Asthma (KALOS) [Online]. Available
at: https://clinicaltrials.gov/study/NCT04609878?limit=25&term=KALOS&rank=1.
[Last accessed: May 2025].
2. Clinicaltrials.gov. Study to Assess
PT010 in Adult and Adolescent Participants with Inadequately
Controlled Asthma (LOGOS) [Online]. Available
at: https://clinicaltrials.gov/study/NCT04609904?limit=25&term=LOGOS&rank=4.
[Last accessed: Mayl 2025].
3. Global Asthma Network. The Global
Asthma Report 2022. [Online]. Available
at: http://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf.
[Last accessed: May 2025].
4. Davis
J, et
al. Burden of asthma among
patients adherent to ICS/LABA: A real-world
study. J Asthma. 2019 Mar;56(3):332-340.
5. Buhl
R, et
al. One-year follow up of
asthmatic patients newly initiated on treatment with medium- or
high-dose inhaled corticosteroid-long-acting b2-agonist in UK
primary care settings. Respir Med. 2020 Feb: 162:105859.
6. U.S. Centers for Disease Control
and Prevention (CDC). Most Recent National Asthma Data. [Online].
Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm.
[Last accessed: May 2025].
7. Fernandes
AG, et
al. Risk factors for death in
patients with severe asthma. J Bras
Pneumol. 2014; 40 (4):
364-372.
8. Clinicaltrials.gov. A 12-week Study
to Assess the Efficacy and Safety of Budesonide and Formoterol
Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose
Inhaler in Participants with Inadequately Controlled Asthma
(LITHOS) [Online]. Available at: https://clinicaltrials.gov/study/NCT05755906?limit=25&term=LITHOS&rank=1.
[Last Accessed: May 2025].
9. Clinicaltrials.gov. A 24-Week
Efficacy and Safety Study to Assess Budesonide and Formoterol
Fumarate Metered Dose Inhaler in Adult and Adolescent Participants
with Inadequately Controlled Asthma (VATHOS) [Online]. Available
at: https://clinicaltrials.gov/study/NCT05202262?limit=25&term=VATHOS&rank=1.
[Last Accessed: May 2025].
10. AstraZeneca
Data on File. 2025. REF-270910.
Matthew Bowden
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.
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AstraZeneca
PLC
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Date:
02 May 2025
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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