REG - AstraZeneca PLC - Update on RESOLUTE Phase III trial

AstraZenecaAnnouncement

17/09/2025 07:00

For best results when printing this announcement, please click on link below:
https://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20250917:nRSQ6039Za&default-theme=true

RNS Number : 6039Z  AstraZeneca PLC  17 September 2025

 

17 September 2025

Update on the RESOLUTE Phase III trial for Fasenra in chronic obstructive
pulmonary disease

The RESOLUTE Phase III trial of AstraZeneca's Fasenra (benralizumab), despite
showing numerical improvement, did not achieve statistical significance in the
primary endpoint in patients with chronic obstructive pulmonary disease
(COPD). i  (#_ftn1)

 

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D,
AstraZeneca, said: "COPD, which remains a leading cause of death worldwide, is
a complex, heterogeneous disease and we continue to advance other promising
approaches in our pipeline to address the unmet needs of patients. With its
well-established ability to target and eliminate eosinophils, Fasenra has
helped transform treatment of severe asthma, and more recently has
demonstrated a significant effect in eosinophilic granulomatosis with
polyangiitis and hypereosinophilic syndrome."

 

The safety and tolerability profile for Fasenra in the trial was consistent
with the known profile of the medicine.(1) The Company will analyse the full
data set from RESOLUTE to further understand the results, which will be shared
with the scientific community in the future.

 

Fasenra is currently approved as an add-on maintenance treatment for severe
eosinophilic asthma (SEA) in more than 80 countries, including the US, Japan,
EU and China.(2-5) It is also approved for SEA in children and adolescents
ages six and above in the US and Japan.(6) Fasenra is also approved in more
than 60 countries for the adult treatment of eosinophilic granulomatosis with
polyangiitis (EGPA),(7) and is under regulatory review for the treatment of
hypereosinophilic syndrome (HES).

Notes

 

COPD

COPD is a debilitating, irreversible and progressive disease.(8-11) COPD
exacerbations are life-threatening and accelerate disease progression,
irreversible lung damage, increased hospitalisations, subsequent exacerbations
and death.(8-12) COPD is one of the most common chronic respiratory diseases,
affecting 391 million people globally,(8) and is among the highest causes of
morbidity and mortality globally.(13)( )

 

RESOLUTE

RESOLUTE is a randomised, double-blind, placebo-controlled Phase III trial to
evaluate the efficacy and safety of benralizumab 100 mg in people with
moderate to very severe COPD with a history of frequent COPD exacerbations and
an elevated blood eosinophil count (BEC) ≥ 300 cells/µL.(1,4) Participants
in the trial had a history of at least two COPD exacerbations in the year
prior to enrolment, were on background treatment with ICS/LABA/LAMA and were a
current or former smoker.(14) The primary endpoint was the annualised rate of
moderate or severe exacerbations in patients with three or more exacerbations
in the previous year. The RESOLUTE trial population was informed by the
analysis from the Phase III GALATHEA and TERRANOVA
(https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30338-8/fulltext)
trials.

 

Participants (n=689) were randomised to receive placebo-solution or Fasenra
(100 mg every four weeks for the first three doses and then every eight weeks
thereafter).(14) All participants remained on their background therapy,
ICS/LABA/LAMA.(14)

 

In the trial, moderate COPD exacerbations were defined by symptomatic
worsening of COPD requiring the use of systemic corticosteroids for at least
three days and use of antibiotics.(14) Severe exacerbations were defined by
hospitalisation or death due to COPD.(14) Key secondary endpoints included the
annualised rate of severe exacerbations, change from baseline in SGRQ total
score; and change from baseline in pre-dose/pre-bronchodilator FEV1 at Week
56.(14)

 

Fasenra

Fasenra (benralizumab) is currently approved as an add-on maintenance
treatment for adults with SEA in more than 80 countries, including the US,
Japan, EU and China.(2-5) More than 150,000 patients globally are currently
taking Fasenra.(15) In the US and Japan, Fasenra is also approved in SEA
patients six years and older.(6)  Fasenra is also approved in more than 60
countries for the treatment of eosinophilic granulomatosis with polyangiitis
(EGPA) in adults.(7)

 

The NATRON Phase III trial evaluating Fasenra (benralizumab) in people with
hypereosinophilic syndrome (HES) successfully met the primary endpoint.
Fasenra, dosed monthly in a single injection, demonstrated a statistically
significant increase in the time to first worsening or flare compared to
placebo.(16)

 

Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a
wholly owned subsidiary of Kyowa Kirin Co., Ltd., Japan.

 

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
(https://gateway.zscalertwo.net/auD?origurl=https:%2f%2fwww.linkedin.com%2fcompany%2fastrazeneca&_ordtok=Mkk3WV5DBDPmQrD4F5MGdGDMZR)
.
(https://gateway.zscalertwo.net/auD?origurl=https:%2f%2fwww.linkedin.com%2fcompany%2fastrazeneca&_ordtok=Mkk3WV5DBDPmQrD4F5MGdGDMZR)
 

 

Contacts

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

 

References

1.   Wechsler ME, et al. Benralizumab versus Mepolizumab for Eosinophilic
Granulomatosis with Polyangiitis. N Engl J Med. 2024;390(10):911-921.

2.   Fasenra (benralizumab) US prescribing information. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070s021lbl.pdf
(https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761070s021lbl.pdf)
. [Last accessed: September 2025].

3.   EMA Fasenra Product Information. Available at:
https://www.ema.europa.eu/en/documents/product-information/fasenra-epar-product-information_en.pdf.
[Last accessed: September 2025].

4.   AstraZeneca news release. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-china-for-the-treatment-of-severe-eosinophilic-asthma.html
(https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-china-for-the-treatment-of-severe-eosinophilic-asthma.html)
[Last accessed: September 2025]

5.   AstraZeneca news release. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2018/fasenra-recieves-approval-in-japan-19012018.html#
(https://www.astrazeneca.com/media-centre/press-releases/2018/fasenra-recieves-approval-in-japan-19012018.html)
[Last accessed: September 2025].

6.   AstraZeneca Annual Report 2024. Available at: Annual report 2024
(https://www.astrazeneca.com/investor-relations/annual-reports/annual-report-2024.html)
. [Last accessed: September 2025].

7.   AstraZeneca Data on File. 2025. Fasenra Program Update August 2025.
REF-287072.

8.   Adeloye D, et al. Global, regional, and national prevalence of, and
risk factors for, chronic obstructive pulmonary disease (COPD) in 2019: a
systematic review and modelling analysis. Lancet Respir Med.
2022;6(10):447-456

9.   Kim G-D, et al. Macrophage Polarization and Functions in Pathogenesis
of Chronic Obstructive Pulmonary Disease. Int J Mol Sci. 2024;25(11):5632.

10.  Vogelmeier CF, AstraZeneca H1 and Q2 Results. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2025/h1-and-q2-2025.html
(https://www.astrazeneca.com/media-centre/press-releases/2025/h1-and-q2-2025.html)
. [Last accessed: September 2025]Goals of COPD treatment: Focus on symptoms
and exacerbations. Respir Med. 2020;166:105938.

11.  Quaderi SA, Hurst JR. The unmet global burden of COPD. Global Health,
Epid and Geno. 2018;3,e4.

12.  Alwafi H, et al. Trends in hospital admissions and prescribing due to
chronic obstructive pulmonary disease and asthma in England and Wales between
1999 and 2020: an ecological study. BMC Pulm Med. 2023;34(2):49.

13.  WHO Fact Sheet. The Top 10 Causes of Death. Available at:
https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death
(https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death)
. [Last accessed: September 2025].

14.  Clinicaltrial.gov. Efficacy and Safety of Benralizumab in Moderate to
Very Severe Chronic Obstructive Pulmonary Disease (COPD) With a History of
Frequent Exacerbations (RESOLUTE). Available at:
https://clinicaltrials.gov/study/NCT04053634.
(https://clinicaltrials.gov/study/NCT04053634.) [Last accessed: September
2025].

15.  AstraZeneca Data on File. 2025. Fasenra Number of Cumulative Patients.
REF-279705.

16.  AstraZeneca H1 and Q2 Results 2025. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2025/h1-and-q2-2025.html
(https://www.astrazeneca.com/media-centre/press-releases/2025/h1-and-q2-2025.html)
. [Last accessed: September 2025].

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

 i  (#_ftnref1) The primary endpoint was the annualised rate of moderate or
severe chronic obstructive pulmonary disease (COPD) exacerbations.

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDEAFNKFDFSEAA