REG - AstraZeneca PLC - Breztri met primary endpoints in Ph3 asthma trials

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RNS Number : 1481H  AstraZeneca PLC  02 May 2025

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 (320/28.8/9.6μg)) 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 (320/28.8/9.6μg and
320/14.4/9.6μg) 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 320/28.8/9.6μg 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 (https://www.astrazeneca.com/)

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 (http://www.astrazeneca.com/)  and follow the
Company on social media @AstraZeneca
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Contacts

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.

 

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
(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
(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
(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
β2-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
(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
(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
(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

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