Rome, November 13 (Adnkronos Health) – In patients with treatment-resistant hypertension (rHtn), baxdrostat, after 12 weeks of treatment, demonstrated a statistically significant and of high clinical relevance reduction in mean 24-hour systolic blood pressure (Sbp) of 14.0 mmHg, normalized to placebo. These are positive results from the phase 3 Bax24 study – released by AstraZeneca in a note – in which patients received baxdrostat at a dose of 2 mg or placebo in addition to standard therapy. Efficacy was observed throughout the 24-hour period, including early morning, when subjects with arterial hypertension are at higher risk of cardiovascular events. Baxdrostat was generally well tolerated, with a safety profile consistent with BaxHtn studies. Complete results of the Bax24 Study were presented at the final session ‘Emerging Opportunities for Managing Cardiometabolic Syndrome’ at the 2025 American Heart Association (AHA) Congress. The data will be shared with regulatory authorities globally.
In addition to meeting the primary endpoint, baxdrostat demonstrated statistically significant and clinically relevant reductions in blood pressure across key secondary endpoints, including dynamic monitoring of mean systolic blood pressure at night (13.9 mmHg normalized to placebo) and in the sitting position (10.3 mmHg normalized to placebo) consistent with the results of the BaxHtn study. Significantly more patients treated with baxdrostat (71%) achieved a mean 24-hour systolic blood pressure of less than 130 mmHg compared with patients treated with placebo (17%).
“Treatment-resistant arterial hypertension is a condition that has a strong impact on the daily life of patients who, despite taking 3 or more antihypertensive drugs, often fail to achieve adequate blood pressure control, thus significantly increasing the risk of developing cardiovascular and renal diseases”, comments Gianfranco Parati, honorary professor of Cardiovascular Medicine, University of Milan-Bicocca, scientific director of the Italian Auxological Institute Irccs Milan and president of the World Hypertension League. “In this context – he added – the results of the phase III Bax24 study are particularly important, showing how baxdrostat 2 mg significantly reduced 24-hour monitored systolic blood pressure by 14.0 mmHg, compared with placebo, in patients with resistant arterial hypertension, with efficacy maintained both day and night, a sign of significant clinical impact. These results demonstrate the clinical potential of baxdrostat to address an important unmet therapeutic need, potentially enabling an ever-increasing number of patients to achieve sustainable blood pressure control over time time, with a positive impact in reducing cardiovascular and renal risks.”
According to Bryan Williams, Chair of Medicine at University College London, Principal Investigator of the study, this is “the result of a major clinical impact and has the potential to change clinical practice. A reduction of this magnitude, associated with the fact that more than 70% of patients treated with baxdrostat achieved the guideline-recommended blood pressure targets sustainably over a 24-hour period, is a highly significant result.” For Sharon Barr, Executive Vice President, BioPharmaceuticals Research and Development, “data from the Bax24 Study demonstrate the significant impact of baxdrostat’s long half-life and highly selective inhibition of aldosterone synthase in improving 24-hour and overnight systolic blood pressure for patients with resistant hypertension, who are highly susceptible to cardiovascular events, including heart attack and stroke. These data and the results of the BaxHtn Study, highlight the potential for baxdrostat to redefine treatment options for the millions of patients whose hypertension persists.” controlled even though therapy is available.”
In the world, 1.4 billion people live with hypertension – experts recall – This pathology affects about 30% of the Italian population. Constant 24-hour blood pressure control is an important clinical outcome in patients with difficult-to-control hypertension. A number of studies have shown that blood pressure measured over 24 hours is a more reliable indicator of cardiovascular event prediction than measurements taken in the office. An increase in mean 24-hour systolic blood pressure of 9.5 mmHg was associated with a 30% increased risk of all-cause mortality.
Baxdrostat – reports the pharmaceutical company – is designed to lower blood pressure by inhibiting the production of aldosterone, one of the hormones responsible for high blood pressure and increasing cardiovascular and kidney risks. Phase I studies show that the drug reaches maximum blood concentrations within 2-4 hours after administration, with a half-life of between 26 and 30 hours. The molecule is currently being studied, as monotherapy in addition to standard care, for the treatment of arterial hypertension and primary aldosteronism, as well as in combination with dapagliflozin for chronic kidney disease and for the prevention of heart failure in high-risk patients.
