Adnkronos Rome, November 13 (Adnkronos Salute) – In patients with treatment-resistant hypertension (rHTN), baxdrostat demonstrated a statistically significant and highly clinically relevant reduction in mean systolic blood pressure (SBP) over 24 hours of 14,0 mmHg, normalized for placebo, after 12 weeks of treatment. These are the positive results of the Phase 3 Bax24 study – released by AstraZeneca in a press release – 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 the early morning hours, when subjects with hypertension are at higher risk of cardiovascular events. Baxdrostat was generally well tolerated, with a safety profile consistent with that of the BaxHtn study. Full results from the Bax24 study were presented in the late-breaking session "Emerging Opportunities for Managing Cardiometabolic Syndrome" at the American Heart Association (AHA) 2025 Scientific Sessions. The data will be shared with regulatory authorities globally.
In addition to meeting the primary endpoint, baxdrostat demonstrated statistically significant and clinically meaningful blood pressure reduction in key secondary endpoints, including mean 24-hour systolic blood pressure (SBP) at night (13,9 mmHg normalized to placebo) and in the sitting position (10,3 mmHg normalized to placebo), consistent with results from the BaxHtn study. Significantly more patients treated with baxdrostat (71%) achieved a mean 24-hour systolic blood pressure less than 130 mmHg compared to patients treated with placebo (17%).
"Treatment-resistant hypertension is a condition that severely impacts the daily lives of patients who, despite taking three or more antihypertensive medications, often fail to achieve adequate blood pressure control, significantly increasing the risk of cardiovascular and renal events," commented Gianfranco Parati, Honorary Professor of Cardiovascular Medicine at the University of Milan-Bicocca, Scientific Director of the Istituto Auxologico Italiano IRCCS Milan, and President of the World Hypertension League. "In this context," he added, "the results of the Phase III Bax24 study are extremely important, demonstrating that baxdrostat 2 mg significantly reduces 24-hour systolic blood pressure by 14,0 mmHg, compared to placebo, in patients with resistant arterial hypertension, with efficacy maintained both during the day and at night, a finding of significant clinical impact. These results demonstrate the clinical potential of baxdrostat to fill a significant unmet therapeutic need, potentially allowing an increasing number of patients to achieve sustained blood pressure control over time, with a positive impact on reducing cardiovascular and renal risk."
According to Bryan Williams, Chair of Medicine at University College London and Principal Investigator of the study, this is "a result of great clinical impact and potentially transformative clinical practice. A reduction of this magnitude, coupled with the fact that just over 70% of patients treated with baxdrostat achieved guideline-recommended blood pressure targets sustainably across the entire 24-hour period, represents a truly significant result." According to Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, "the data from the Bax24 Study demonstrate the significant impact that baxdrostat's long half-life and its highly selective inhibition of aldosterone synthase can have in improving 24-hour and nighttime systolic blood pressure in patients with resistant hypertension, who are particularly vulnerable to cardiovascular events, including heart attack and stroke. These data, and the results of the BaxHtn Study, highlight the potential of baxdrostat to redefine therapeutic options for the millions of patients whose hypertension remains uncontrolled despite currently available therapies."
Worldwide, 1,4 billion people live with hypertension – experts point out – The condition affects approximately 30% of the Italian population. Consistent 24-hour blood pressure monitoring is an important clinical outcome for patients with difficult-to-control hypertension. Numerous studies have shown that 24-hour blood pressure is a more reliable predictor of cardiovascular events than office-based blood pressure measurements. A 9,5 mmHg increase in mean 24-hour systolic blood pressure is associated with a 30% increased risk of all-cause mortality.
Baxdrostat, according to the pharmaceutical company, is designed to reduce blood pressure by inhibiting the production of aldosterone, one of the hormones responsible for high blood pressure and increased cardiovascular and renal risk. Phase I studies have shown that it reaches peak blood concentrations within 2–4 hours of administration, with a half-life of 26–30 hours. The molecule is currently being studied as a monotherapy in addition to standard of 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.