AstraZeneca's aldosterone synthase inhibitor baxdrostat reduced blood pressure by 14 mmHg over 12 weeks, the pharma has said in a first look at the data from a key phase 3 win.
Baxdrostat has a half-life of 26 to 30 hours, compared to 10 to 12 hours for Mineralys Therapeutics’ rival aldosterone synthase inhibitor lorundrostat.
AstraZeneca, which paid $1.3 billion upfront for baxdrostat developer CinCor Pharma in 2023, ran the phase 3 Bax24 trial to support its case that this extended half-life amounts to a serious competitive advantage. For the study, investigators enrolled 218 people with treatment-resistant hypertension to receive baxdrostat or placebo on top of standard of care.
The Big Pharma already announced last month that the study had hit its primary endpoint by demonstrating a significant drop in ambulatory 24-hour average systolic blood pressure (SBP) in the baxdrostat cohort compared to the placebo group.
The company arrived at the American Heart Association 2025 Scientific Sessions on Sunday armed with the data to back up this success. Specifically, baxdrostat was tied to a 14 mmHg placebo-adjusted reduction in ambulatory SBP.
While directly comparing trials should be treated with caution, lorundrostat has been tied to a 7.9 mmHg placebo-adjusted drop in blood pressure at 12 weeks.
When it came to secondary endpoints of ambulatory nighttime average SBP and seated SBP, baxdrostat demonstrated “statistically significant and clinically meaningful” reductions of 13.9 mmHg and 10.3 mmHg, respectively, AstraZeneca told the conference.
The company reaffirmed that it would share these data “with regulatory authorities around the world,” although AstraZeneca didn’t outline a timeline for approval in the release.
The anticipated launch is part of the drugmaker’s plans to grow sales to $80 billion by 2030 and follows a phase 3 win in the BaxHTN trial that looked at seated SBP earlier this year.
“The Bax24 data demonstrate the significant impact that baxdrostat’s long half-life and highly selective inhibition of aldosterone synthase can have in improving 24-hour and overnight blood pressure for patients with resistant hypertension,” Sharon Barr, executive vice president, biopharmaceuticals R&D, said in a statement.
“Patients with elevated night-time blood pressure are especially vulnerable to cardiovascular events, including heart attack and stroke,” Barr added. “Together with the results from BaxHTN, these findings demonstrate the potential of baxdrostat to redefine what is possible for the millions of patients whose hypertension remains uncontrolled despite current therapies.”
Baxdrostat is heading toward a potential battle with lorundrostat. Mineralys has arranged a prefiling meeting with the FDA for the fourth quarter to discuss a submission based on its own recent wins in the clinic.