REG - AstraZeneca PLC - Baxdrostat met primary endpoint in Bax24 Ph3 trial

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RNS Number : 2840C  AstraZeneca PLC  07 October 2025

7 October 2025

 

Baxdrostat met the primary endpoint in Bax24 Phase III trial in patients with
resistant hypertension

Baxdrostat demonstrated a statistically significant and highly clinically
meaningful reduction in 24-hour ambulatory systolic blood pressure compared
with placebo

Positive high-level results from the Bax24 Phase III trial showed baxdrostat
demonstrated a statistically significant and highly clinically meaningful
reduction in ambulatory 24-hour average systolic blood pressure (SBP) compared
with placebo at 12 weeks. Efficacy was observed throughout the 24-hour period,
including early morning, when patients with hypertension are at a higher risk
of cardiovascular events.(1-3)

 

Patients with treatment-resistant hypertension (rHTN) received baxdrostat 2mg
or placebo on top of standard of care. Baxdrostat was generally well
tolerated, with a safety profile consistent with the BaxHTN trial.(4)

 

There are 1.4 billion people worldwide living with hypertension.(5) In the US,
approximately 50% of patients living with hypertension on multiple treatments
do not have their blood pressure under control.(6) Consistent 24-hour blood
pressure control is an important clinical outcome in patients with
hard-to-control hypertension.(7-9) Multiple studies have demonstrated that
24-hour blood pressure is a more powerful predictor of cardiovascular events
than a clinic-based measurement.(3,10) When 24-hour average systolic blood
pressure rises by 9.5 mmHg, the risk of all-cause mortality increases by
30%.(3)

 

Dr. Bryan Williams, Chair of Medicine at University College London, primary
investigator, said: "The Bax24 results show that a once-daily baxdrostat
regimen can deliver highly clinically meaningful reductions in 24-hour
systolic blood pressure, including in the morning when patients are at greater
risk of heart attack and stroke. These results are groundbreaking and together
with the BaxHTN results mean we have the potential to change our treatment
approach for the many patients whose hypertension remains uncontrolled despite
current therapies."

 

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, said: "This
second Phase III trial of baxdrostat shows substantial improvement in blood
pressure, which reflects its durable half-life of up to 30 hours and highly
selective inhibition of aldosterone synthase. Too many patients today have
hypertension that remains hard-to-control throughout the day and night, making
them especially vulnerable to cardiac events. We are advancing our regulatory
filings and rapidly progressing our robust clinical development programme for
baxdrostat, as both a mono- and combination-therapy, across additional
conditions where aldosterone plays a key role, including primary
aldosteronism, chronic kidney disease and heart failure prevention."

 

The data will be shared with regulatory authorities around the world and
presented in a late‑breaking session at the American Heart Association (AHA)
Scientific Sessions in November 2025.

 

Baxdrostat is designed to lower blood pressure by specifically inhibiting
aldosterone, a key hormone that raises blood pressure and increases the risk
of heart and kidney problems. Phase I studies show baxdrostat reached peak
levels in the blood within 2 to 4 hours and had a half-life of about 26 to 30
hours.(11,12) Baxdrostat is currently being investigated as a monotherapy for
hypertension(13-15) and primary aldosteronism,(16) and in combination with
dapagliflozin for chronic kidney disease(17,18) and the prevention of heart
failure in high-risk patients.(19)

 

Notes

 

Hard-to-control hypertension

Hypertension is a medical condition characterised by consistently high blood
pressure levels, affecting an estimated 1.4 billion people worldwide.(4,20,21)
Over time, this can damage blood vessels and vital organs, increasing the risk
of serious health problems such as heart attack, stroke, heart failure and
kidney disease.(20,21) An observational study of nearly 60,000 patients
studied over a median of 9.7 years showed that a 9.5 mmHg increase in SBP was
associated with a 30% increase in risk of all-cause mortality and 41% increase
in risk of cardiovascular death.(10)Studies have shown that increased
night-time blood pressure is associated with higher cardiovascular risk,(7,10)
and patients with hypertension have a higher risk of cardiovascular events
like heart attack, stroke and death around the time of their morning blood
pressure surge.(1,2)

 

Hard-to-control (uncontrolled and resistant) hypertension remains a major
public health challenge.(22) Despite lifestyle changes and the use of multiple
medications, approximately 50% of patients in the US who are being treated for
hypertension still do not have their blood pressure under control.(5)
Uncontrolled hypertension refers to persistently elevated blood pressure
despite the use of two or more medications, while rHTN, a more severe form,
remains elevated despite treatment with three or more medications.(5,20)

 

A key contributor to hard-to-control hypertension is aldosterone, a hormone
that raises blood pressure by promoting sodium and water retention.(23,24)
Elevated aldosterone levels, along with factors such as obesity, high salt
intake, and various genetic or secondary conditions,(25) are strongly
associated with poor blood pressure control. When left untreated, hypertension
significantly increases the risk of cardiovascular and kidney-related
complications.(20,21)

 

Bax24 trial

The Phase III Bax24 trial(15) is a randomised, double-blind,
placebo-controlled, parallel group study to evaluate the safety, tolerability
and the effect of 2mg baxdrostat versus placebo, administered once a day (QD)
orally, on the reduction of ambulatory SBP in participants with rHTN. A total
of 218 patients were randomised in a 1:1 ratio to receive baxdrostat 2mg or
placebo once daily during a 12-week double blind period. The primary efficacy
endpoint was the change from baseline in ambulatory 24-hour average SBP at
Week 12.

 

Additional secondary endpoints include the effect of baxdrostat versus placebo
on change from baseline in ambulatory night-time average SBP at Week 12,
change from baseline in ambulatory daytime average SBP at Week 12, change from
baseline in seated SBP at Week 12, the number of participants achieving
ambulatory 24-hour average SBP of less than 130 mmHg at Week 12 and the number
of participants achieving a nocturnal SBP dipping of greater than 10% at Week
12. Occurrence of adverse events was evaluated during the 12-week treatment
period as well as during a 2-week safety follow-up period.

 

Baxdrostat

Baxdrostat is a potential first-in-class, highly selective and potent, oral,
small molecule that inhibits aldosterone synthase,(11) an enzyme encoded by
the CYP11B2 gene, which is responsible for the synthesis of aldosterone in the
adrenal gland.(23) In clinical trials, baxdrostat was observed to
significantly lower aldosterone levels without affecting cortisol levels
across a wide range of doses.(12,26) Baxdrostat is currently being
investigated in clinical trials as a monotherapy for hypertension(13-15) and
primary aldosteronism,(16) and in combination with dapagliflozin for chronic
kidney disease and hypertension,(17,18) and the prevention of heart failure in
patients with hypertension.(19)

 

AstraZeneca acquired baxdrostat through its purchase of CinCor Pharma, Inc. in
February 2023.(27)

 

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

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.

 

References

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12.  Freeman MW, et al. Results from a phase 1, randomized, double-blind,
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Available at: https://clinicaltrials.gov/study/NCT06344104. Accessed September
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Ambulatory Blood Pressure in Participants With Resistant Hypertension (Bax24).
Available at:  https://clinicaltrials.gov/study/NCT06168409. Accessed
September 2025.

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in Participants With Primary Aldosteronism (BaxPA). Available at:
https://clinicaltrials.gov/study/NCT07007793. Accessed September 2025.

17.  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 September 2025.

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https://clinicaltrials.gov/study/NCT06677060. Accessed September 2025.

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Accessed September 2025.

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million participants. Lancet. 2021 Sep 11;398(10304):957-980. doi:
10.1016/S0140-6736(21)01330-1.

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cardiovascular physiology and pathophysiology. Oxid Med Cell Longev.
2018;2018:1204598. Accessed September 2025.

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coronary artery calcium: The multi-ethnic study of atherosclerosis.
Hypertension. 2020;76(1):113-120. Accessed September 2025.

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27.  AstraZeneca 2023. Acquisition of CinCor Pharma complete.
https://www.astrazeneca.com/media-centre/press-releases/2023/astrazeneca-acquires-cincor-for-cardiorenal-asset.html.
Accessed September 2025.

 

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

 

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