AstraZeneca Announces Positive Phase 3 Bax24 Trial Results for Baxdrostat in Resistant Hypertension

On November 11, AstraZeneca announced the positive full results of the Bax24 Phase 3 trial, showing that baxdrostat Achieves Statistically and Clinically Significant Reduction in 24-Hour Average Systolic Blood Pressure (SBP) at 12 WeeksPatients with refractory hypertension (rHTN) who received baxdrostat 2mg or placebo on the basis of standard treatment showed efficacy throughout a 24-hour period, including the early morning hours when cardiovascular event risk is higher for hypertensive patients.

Baxdrostat Achieves Primary Endpoint in Bax24 Phase 3 Trial, Demonstrating Clinically Meaningful and Sustained Blood Pressure Reduction in Patients with Resistant Hypertension.At Week 12, the placebo-corrected reduction in 24-hour ambulatory mean systolic blood pressure was 14.0 mmHg.The product was generally well-tolerated, with safety characteristics consistent with the BaxHTN trial.

Baxdrostat also demonstrated statistically and clinically significant reductions in several key secondary endpoints, including nighttime ambulatory mean systolic blood pressure (a placebo-adjusted reduction of 13.9 mmHg) and seated systolic blood pressure (a placebo-adjusted reduction of 10.3 mmHg), consistent with the data from the BaxHTN trial. A significantly higher proportion of patients treated with Baxdrostat (71%) achieved a 24-hour mean systolic blood pressure <130 mmHg compared to those on placebo (17%).

The results of the Bax24 Phase 3 study indicate that,Hypertensive patients with the most difficult-to-control blood pressure experienced a 14 mmHg reduction in 24-hour systolic blood pressure, placebo-adjusted, after receiving baxdrostat, a result of significant clinical importance. Additionally, over 70% of patients treated with the drug maintained blood pressure levels continuously reaching guideline-recommended targets within 24 hours.

AstraZeneca's press release stated that the research data fully demonstrates that baxdrostat, with its long half-life and high selectivity in inhibiting aldosterone synthase, can significantly improve 24-hour blood pressure and nighttime blood pressure in patients with resistant hypertension. Patients with elevated nighttime blood pressure are more prone to cardiovascular events such as myocardial infarction and stroke.

According to the latest research from the World Health Organization (WHO) in 2025, there are 1.4 billion people with hypertension globally. Refractory hypertension refers to persistently elevated blood pressure despite treatment with two or more antihypertensive medications. Achieving 24-hour continuous blood pressure control is one of the crucial clinical outcomes for patients with refractory hypertension. Multiple studies have shown that, compared to office blood pressure measurements, 24-hour blood pressure monitoring can more effectively predict cardiovascular events. For every 9.5 mmHg increase in 24-hour average systolic blood pressure, the risk of all-cause mortality increases by 30%.

Data from the Bax24 trial will be shared with regulatory agencies around the world.

Baxdrostat is a highly selective and potent oral small-molecule drug that lowers blood pressure by specifically inhibiting aldosterone synthesis.Aldosterone is a key hormone responsible for elevated blood pressure and increased cardiovascular and renal risks. Currently, the drug is being evaluated as a monotherapy for hypertension and primary aldosteronism, and in combination with dapagliflozin for the treatment of chronic kidney disease as well as the prevention of heart failure in high-risk patients.

References:
[1] Baxdrostat demonstrated a statistically and clinically significant reduction in 24-hour ambulatory systolic blood pressure in patients with resistant hypertension in the Bax24 Phase III trial, with a placebo-adjusted decrease of 14.0 mmHg. From https://www.prnasia.com/story/511310-1.shtml

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