REG - AstraZeneca PLC - Baxdrostat met primary endpt in BaxHTN PhIII trial

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RNS Number : 9001Q  AstraZeneca PLC  14 July 2025

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 hypertension(8,9) 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 trial(7) 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 hypertension(7-9) and primary aldosteronism,(10) and in
combination with dapagliflozin for chronic kidney disease(11,12) 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
(https://www.astrazeneca.com/our-therapy-areas/cardiovascular-renal-and-metabolism.html)
 

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 (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://www.linkedin.com/company/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. 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.

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