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 July 2025
Commission
File Number: 001-11960
AstraZeneca PLC
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Baxdrostat met primary endpt in BaxHTN PhIII trial
This announcement contains inside information
14 July 2025
Baxdrostat met the primary and all secondary endpoints in BaxHTN
Phase III trial in patients with uncontrolled or treatment
resistant hypertension
Baxdrostat demonstrated a statistically significant and clinically
meaningful reduction of systolic blood pressure compared with
placebo
Positive high-level results from the BaxHTN Phase III trial showed
baxdrostat at two doses (2mg and 1mg) demonstrated a statistically
significant and clinically meaningful reduction in mean seated
systolic blood pressure (SBP) compared with placebo at 12 weeks.
The trial also successfully met all secondary endpoints. Patients
with uncontrolled or treatment resistant hypertension received
baxdrostat or placebo on top of standard of care. Baxdrostat was
generally well tolerated with a favourable safety
profile.
There are 1.3 billion people worldwide living with
hypertension.1 When
uncontrolled, hypertension can lead to a higher risk of heart
attack, stroke, heart failure and kidney
disease.2,3 In
the US, approximately 50% of hypertensive patients who are on
multiple treatments do not have their blood pressure under
control.4 Growing
evidence points to aldosterone dysregulation as one of the key
biological drivers of hypertension.5,6
Dr. Bryan Williams, Chair of Medicine at University College London,
primary investigator, said: “Many people continue to
struggle with high blood pressure that is hard to control, even
when taking multiple medications. The highly promising BaxHTN Phase
III results show that once-daily baxdrostat on top of standard of
care can meaningfully lower systolic blood pressure and offer a
potential new treatment approach for controlling hypertension, the
leading risk factor for cardiovascular
disease.”
Sharon Barr, Executive Vice President, BioPharmaceuticals R&D,
said: “We are very excited with the BaxHTN Phase III
results, which show statistically significant and clinically
meaningful reductions in systolic blood pressure. These findings
provide compelling evidence of baxdrostat’s potential to
address a critical unmet need by targeting aldosterone
dysregulation, bringing a novel mechanism to a field that has seen
little innovation in over two decades.”
BaxHTN is a Phase III, multicentre, randomised, double-blinded,
placebo-controlled, parallel group study to evaluate the safety,
tolerability and effect of baxdrostat in patients with uncontrolled
hypertension being treated with two different antihypertensive
medications and patients with resistant hypertension being treated
with three or more different antihypertensive medications, one of
which is a diuretic.7
The data will be shared with regulatory authorities around the
world and presented in a late-breaking Hot Line session at the European Society
of Cardiology (ESC) Congress in
August 2025.
Baxdrostat is a potential first-in-class, highly selective
aldosterone synthase inhibitor (ASI) that targets the hormone
driving elevated blood pressure and increased cardiovascular and
renal risk. It is currently being investigated in clinical trials
as a monotherapy for hypertension8,9 and
primary aldosteronism,10 and
in combination with dapagliflozin for chronic kidney disease and
the prevention of heart failure in high-risk hypertensive
patients.11-13
Notes
Hypertension that is hard to control
Hypertension is a medical condition characterised by consistently
high blood pressure levels.2,3 Over
time, this can damage blood vessels and vital organs, increasing
the risk of serious health problems.2,3 Hypertension
that is hard to control remains a significant public health
challenge.1 Despite
lifestyle changes and the use of multiple medications, a
significant majority of people with hypertension do not achieve
their blood pressure goals.1,4 Uncontrolled
hypertension persists despite treatment with two or more
medications, while resistant hypertension, a more severe form,
remains elevated despite treatment with three or more
medications.2,4
A key contributor of hypertension that is hard to control is
aldosterone, a hormone that increases blood pressure by promoting
sodium and water retention.5,6 Elevated
aldosterone levels, along with factors like obesity, high salt
intake and various genetic and secondary
conditions,14 are
strongly linked to poor blood pressure control. If left untreated,
the condition significantly increases the risk of heart attack,
stroke and kidney decline.2,3
BaxHTN trial
The BaxHTN Phase III trial7 had
three components to it that support the following endpoints: The
primary endpoint was assessed during a 12-week double-blind,
placebo-controlled period. A total of 796 patients were randomised
in a 1:1:1 ratio to receive baxdrostat 2mg, 1mg or placebo once
daily. The primary efficacy endpoint was the difference in mean
change from baseline in seated SBP at Week 12 between participants
treated with baxdrostat (2mg or 1mg separately) and participants
treated with placebo. Persistence of efficacy was assessed during a
randomised withdrawal period from week 24 to week 32. Approximately
300 patients treated with baxdrostat 2mg were re-randomised in a
2:1 ratio to either continue receiving baxdrostat 2mg or placebo
for the 8 weeks. SBP at the end of the 8 weeks was compared with
placebo and the baxdrostat 2mg dose. Long-term safety is
assessed at the end of the 52 weeks compared to a standard of care
arm.
Additional secondary endpoints include the effect of baxdrostat
versus placebo on seated SBP at Week 12 in the resistant
hypertension subpopulation, the effect of baxdrostat versus placebo
on seated diastolic blood pressure at Week 12, participants
achieving seated SBP less than 130 mmHg at Week 12 and occurrence
of adverse events.
Baxdrostat
Baxdrostat is a potential first-in-class, highly selective and
potent, oral, small molecule that inhibits aldosterone
synthase,15 an
enzyme encoded by the CYP11B2 gene, which is responsible for the
synthesis of aldosterone in the adrenal gland.5 In
clinical trials, baxdrostat was observed to significantly lower
aldosterone levels without affecting cortisol levels across a wide
range of doses.16,17 Baxdrostat
is currently being investigated in clinical trials as a monotherapy
for hypertension7-9 and
primary aldosteronism,10 and
in combination with dapagliflozin for chronic kidney
disease11,12 and
the prevention of heart failure in hypertensive
patients.13
AstraZeneca acquired baxdrostat through its purchase of CinCor
Pharma, Inc. in February 2023.18 A
contingent value right of $10 per share in cash ($0.5 billion) is
payable to former CinCor shareholders upon the submission of a new
drug application either in the US or Europe.18
AstraZeneca
in CVRM
Cardiovascular, Renal and Metabolism (CVRM), part of
BioPharmaceuticals, forms one of AstraZeneca’s main disease
areas and is a key growth driver for the Company. By following the
science to understand more clearly the underlying links between the
heart, kidneys, liver and pancreas, AstraZeneca is investing in a
portfolio of medicines for organ protection by slowing or stopping
disease progression, and ultimately paving the way towards
regenerative therapies. The Company’s ambition is to improve
and save the lives of millions of people, by better understanding
the interconnections between CVRM diseases and targeting the
mechanisms that drive them, so we can detect, diagnose and treat
people earlier and more effectively.
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.
NCD Risk Factor Collaboration (NCD-RisC).
Worldwide trends in hypertension prevalence and progress in
treatment and control from 1990 to 2019: a pooled analysis of 1201
population-representative studies with 104 million
participants. Lancet. 2021;398(10304):957-980.
2.
McEvoy JW, et al. 2024 ESC Guidelines for the
management of elevated blood pressure and
hypertension. EurHeart J. 2024;45(38):3912-4018.
3.
Whelton PK, et al. 2017
ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the
Prevention, Detection, Evaluation, and Management of High Blood
Pressure in Adults: Executive Summary: A Report of the American
College of Cardiology/American Heart Association Task Force on
Clinical Practice Guidelines. Hypertension.
2018;71(6):1269-1324.
4.
Carey RM, et al. Prevalence of apparent
treatment-resistant hypertension in the United States: comparison
of the 2008 and 2018 American Heart Association scientific
statements on resistant hypertension [including online
supplement]. Hypertension.
2019;73(2):424-431.
5.
Cannavo A, et al. Aldosterone and
mineralocorticoid receptor system in cardiovascular physiology and
pathophysiology. Oxid Med Cell
Longev.
2018;2018:1204598.
6.
Inoue K, et al. Serum aldosterone concentration,
blood pressure, and coronary artery calcium: the Multi-Ethnic Study
of Atherosclerosis [including online
supplement]. Hypertension.
2020;76(1):113-120.
7.
ClinicalTrials.gov. A Study to Investigate the
Efficacy and Safety of Baxdrostat in Participants With Uncontrolled
Hypertension on Two or More Medications Including Participants With
Resistant Hypertension (BaxHTN). Available at:
https://clinicaltrials.gov/study/NCT06034743. Accessed June
2025.
8.
ClinicalTrials.gov.
A Study to Investigate the Effect of Baxdrostat on Ambulatory Blood
Pressure in Participants With Resistant Hypertension (Bax24).
Available at: https://clinicaltrials.gov/study/NCT06168409.
Accessed June 2025.
9.
ClinicalTrials.gov. A Study to Investigate the
Efficacy and Safety of Baxdrostat in Participants With Uncontrolled
Hypertension on Two or More Medications Including Participants With
Resistant Hypertension (BaxAsia). Available at:
https://clinicaltrials.gov/study/NCT06344104. Accessed
June 2025.
10.
ClinicalTrials.gov. A Study to Assess Efficacy and
Safety of Baxdrostat in Participants With Primary Aldosteronism
(BaxPA). Available at:
https://clinicaltrials.gov/study/NCT07007793. Accessed
June 2025.
11.
ClinicalTrials.gov. A
Phase III Renal Outcomes and Cardiovascular Mortality Study to
Investigate the Efficacy and Safety of Baxdrostat in Combination
With Dapagliflozin in Participants With Chronic Kidney Disease and
High Blood Pressure (BaxDuo-Pacific). Available
at: https://clinicaltrials.gov/study/NCT06742723. Accessed
June 2025.
12.
ClinicalTrials.gov. A Phase III Study to
Investigate the Efficacy and Safety of Baxdrostat in Combination
With Dapagliflozin on CKD Progression in Participants With CKD and
High Blood Pressure. Available at:
https://clinicaltrials.gov/study/NCT06268873. Accessed
June 2025.
13.
ClinicalTrials.gov.
A Phase III Study
Investigating Heart Failure and Cardiovascular Death With
Baxdrostat in Combination With Dapagliflozin (Prevent-HF).
ClinicalTrials.gov identifier:
NCT06677060. Available
at: https://clinicaltrials.gov/study/NCT06677060. Accessed
June 2025.
14.
van Oort S, et al. Association of cardiovascular
risk factors and lifestyle behaviors with hypertension: a mendelian
randomization study. Hypertension.
2020;76(6):1971-1979.
15.
Bogman K, et al. Preclinical and early clinical
profile of a highly selective and potent oral inhibitor of
aldosterone synthase (CYP11B2). Hypertension.
2017;69:189-96.
16.
Freeman, MW et al. Results from a phase 1,
randomized, double-blind, multiple ascending dose study
characterizing the pharmacokinetics and demonstrating the safety
and selectivity of the aldosterone synthase inhibitor baxdrostat in
healthy volunteers. Hypertens
Res. 2023;(46)108–118.
17.
Freeman MW, et al. Phase 2 Trial of Baxdrostat for
Treatment-Resistant Hypertension. NEJM. 2023;388:395-405
18.
AstraZeneca
2023. Acquisition of CinCor Pharma complete. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-acquires-cincor-for-cardiorenal-asset.html.
Accessed June 2025.
Matthew Bowden
Company Secretary
AstraZeneca PLC
This announcement contains information that AstraZeneca PLC is
obliged to make public pursuant to the EU Market Abuse Regulation
(596/2014) and the assimilated EU Market Abuse Regulation
(596/2014) as it forms part of the law of the United Kingdom by
operation of the European Union (Withdrawal) Act 2018. This
announcement was submitted for publication, through the agency of
the contact person(s) set out above, at 07:00 BST on 14 July
2025.
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: 14 July 2025
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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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