Baxdrostat Shows Promise in Uncontrolled or Resistant Hypertension

The novel aldosterone synthase inhibitor baxdrostat has met its primary and secondary endpoints in the BaxHTN trial of patients with uncontrolled or treatment-resistant hypertension, according to topline results announced by manufacturer AstraZeneca.

At 12 weeks, participants randomized to either 1 mg or 2 mg of baxdrostat once daily had a greater mean change from baseline in seated systolic BP than those on placebo, AstraZeneca said in a press release.

Among the multiple secondary endpoints also met at 12 weeks were change in seated systolic BP from baseline, achieving seated SBP < 130 mm Hg, and low rates of adverse events.

“The highly promising BaxHTN phase III results show that once-daily baxdrostat on top of standard of care can meaningfully lower systolic blood pressure and offer a potential new treatment approach for controlling hypertension, the leading risk factor for cardiovascular disease,” the study’s primary investigator Bryan Williams, MD (University College London, England), said in the press release.

Data from the 796-patient trial are scheduled to be presented in a Hot Line session at the upcoming European Society of Cardiology Congress later this summer, and AstraZeneca said they also will be shared with regulatory authorities.

Additionally, the potential first-in-class agent is being tested in clinical trials as a monotherapy for hypertension (Bax24 and BaxAsia) and primary aldosteronism (BaxPA), and in combination with dapagliflozin (Farxiga; AstraZeneca) for chronic kidney disease and the prevention of heart failure in high-risk patients with hypertension (BaxDuo-Pacific and PREVENT-HF).