AstraZeneca has hailed another phase 3 win for its blood pressure drug candidate baxdrostat, boosting its attempts to turn the molecule’s long half-life into a competitive advantage.
Baxdrostat, an aldosterone synthase inhibitor, has a half-life of 26 to 30 hours. Mineralys Therapeutics’ rival aldosterone synthase inhibitor lorundrostat has a half-life of 10 to 12 hours. Once-daily dosing with lorundrostat improved 24-hour average blood pressure in a phase 2 trial, as well as reducing office blood pressure in a pivotal study, but AstraZeneca has still identified baxdrostat’s half-life as a differentiator.
The Big Pharma, which paid $1.3 billion upfront for baxdrostat developer CinCor Pharma, ran the phase 3 Bax24 trial to support its case. Investigators enrolled 218 people with treatment-resistant hypertension to receive baxdrostat or placebo on top of standard of care.
After 12 weeks of once-daily dosing, AstraZeneca saw a significant drop in ambulatory 24-hour average systolic blood pressure in the baxdrostat cohort compared to the placebo group, achieving the primary endpoint of the trial. The company said efficacy was seen throughout the 24-hour period, including early morning when patients with hypertension are at a higher risk of cardiovascular events.
AstraZeneca is yet to share any numbers from the study, with the only additional finding at this stage being that baxdrostat was generally well tolerated and had a safety profile consistent with an earlier trial. The company will provide a closer look at the data at an event in November.
Management is also preparing to share the data with regulators. Sharon Barr, executive vice president of biopharmaceuticals R&D at AstraZeneca, said in a statement that the company is advancing regulatory filings. AstraZeneca reported a phase 3 win in a trial that looked at seated systolic blood pressure earlier this year. The anticipated launch is part of the drugmaker’s plans to grow sales to $80 billion by 2030.
Baxdrostat could compete against lorundrostat. Mineralys has arranged a pre-filing meeting with the FDA for the fourth quarter to discuss a submission based on its recent wins in the clinic. Boehringer Ingelheim also has an aldosterone synthase inhibitor, vicadrostat, in phase 3, but is targeting chronic kidney disease and heart failure.