AstraZeneca’s baxdrostat has hit the mark in another phase 3 trial involving people who struggle to control their blood pressure with current therapies, keeping the would-be blockbuster on track for regulatory filings this year.
The latest top-line readout from the Bax24 study in patients with resistant hypertension showed that baxdrostat achieved a statistically significant reduction in ambulatory 24-hour average systolic blood pressure (SBP) compared with placebo at 12 weeks, when added to standard care, which AZ said was “highly clinically meaningful.”
The readout comes just a few weeks after AZ reported the results of another phase 3 trial, BaxHTN, which also backed the drug’s efficacy as an add-on therapy for uncontrolled or treatment-resistant hypertension.
The company is in a race to bring the first once-daily, oral aldosterone synthase inhibitor (ASI) to market with Mineralys, which reported positive data in a pair of phase 3 trials of its lorundrostat candidate earlier this year (Advance-HTN and Launch-HTN) and is due to meet with the FDA to discuss filings in the fourth quarter of this year.
AZ has previously said it thinks baxdrostat could become a $5 billion-a-year product, given that around half of the 1.4 billion people living worldwide with high blood pressure are unable to bring it under control with current drugs.
Bax24 lead investigator Dr Bryan Williams, who is chair of medicine at UCL in the UK, said the results show that baxdrostat “can deliver highly clinically meaningful reductions in 24-hour systolic blood pressure, including in the morning when patients are at greater risk of heart attack and stroke.”
Calling the data “groundbreaking,” Williams added that the two baxdrostat studies suggest the drug has the potential to change the treatment approach for patients with uncontrolled high blood pressure.
Last year, Idorsia Pharma claimed FDA approval for Tryvio (aprocitentan) as the first endothelin receptor antagonist for resistant hypertension, adding to the well-established treatment options for patients based on diuretics, calcium channel blockers, and renin-angiotensin system-targeting drugs.
AZ is developing baxdrostat for a range of indications, including chronic kidney disease (CKD) and prevention of heart failure as a combination therapy with its blockbuster SGLT2 inhibitor Farxiga/Forxiga (dapagliflozin), which is approaching the end of its patent life.
Mineralys is taking a similar approach, looking at extending the use of lorundrostat into CKD as well as obstructive sleep apnoea (OSA) with hypertension.
AZ acquired baxdrostat when it bought CinCor Pharma for $1.3 billion in 2023.
