AstraZeneca (AZ) has shared positive results from a late-stage study of its investigational oral aldosterone synthase inhibitor baxdrostat in patients with uncontrolled or treatment resistant hypertension.
The phase 3 BaxHTN trial has been evaluating two doses of the drug in patients with uncontrolled hypertension being treated with two different antihypertensive medications, as well as those with resistant hypertension receiving three or more different antihypertensive medications, including a diuretic.
Both 2mg and 1mg doses of baxdrostat demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) compared with placebo at 12 weeks.
All secondary endpoints were also met, including the effect of baxdrostat versus placebo on seated SBP at week 12 in the resistant hypertension subpopulation, and AZ’s drug was generally well tolerated with a favourable safety profile.
Approximately 1.3 billion people globally are living with hypertension, a condition characterised by consistently high blood pressure levels which, when uncontrolled, can lead to a higher risk of heart attack, stroke, heart failure and kidney disease.
Despite lifestyle changes and the use of multiple medications, around half of hypertensive patients in the US do not have their blood pressure under control.
Baxdrostat, which AZ gained access to in 2023 through its acquisition of CinCor Pharma, is designed to target the hormone driving elevated blood pressure and increased cardiovascular and renal risk.
Sharon Barr, executive vice president, biopharmaceuticals research and development, AZ, said: “We are very excited with the BaxHTN phase 3 results, which show statistically significant and clinically meaningful reductions in SBP.
“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.”
Data from the trial will be shared with regulatory authorities worldwide and presented next month at the European Society of Cardiology Congress, AZ outlined.
Baxdrostat is also currently being evaluated as a monotherapy for primary aldosteronism, and in combination with dapagliflozin for chronic kidney disease and the prevention of heart failure in high-risk hypertensive patients.