Key Takeaways
- AstraZeneca’s blood pressure drug candidate, baxdrostat, has shown significant results in a phase 3 trial for treatment-resistant hypertension.
- The drug’s long half-life offers potential advantages over competitors, including lorundrostat, which has a shorter half-life.
- AstraZeneca plans to advance regulatory filings and present detailed trial data in November.
Phase 3 Trial Results and Competitive Landscape
AstraZeneca has reported a successful phase 3 trial for its blood pressure medication, baxdrostat, which is designed for patients with treatment-resistant hypertension. This positive outcome enhances AstraZeneca’s strategy to use the drug’s longer half-life, approximately 26 to 30 hours, as a key differentiator in the market against competitors like Mineralys Therapeutics’ lorundrostat, which has a shorter half-life of 10 to 12 hours.
In the phase 3 Bax24 trial, 218 participants were enrolled to receive either baxdrostat or a placebo alongside their standard care. After 12 weeks of daily dosing, the baxdrostat group exhibited a notable reduction in ambulatory 24-hour average systolic blood pressure compared to the placebo group. The trial demonstrated efficacy throughout the entire day, which is critical as patients with hypertension face a higher risk of cardiovascular issues, especially in the early morning.
While AstraZeneca has yet to disclose specific numerical results from the study, preliminary findings indicate that baxdrostat was generally well tolerated, maintaining a safety profile consistent with an earlier phase 2 study. The pharmaceutical company plans to present comprehensive data at an upcoming event in November, which is anticipated to inform future regulatory discussions.
Sharon Barr, the executive vice president of biopharmaceuticals research & development at AstraZeneca, emphasized the company’s commitment to advancing regulatory filings for baxdrostat. This phase 3 success follows another positive trial earlier this year, focusing on seated systolic blood pressure, and aligns with AstraZeneca’s broader goal of reaching $80 billion in sales by 2030.
Baxdrostat will enter a competitive arena, particularly against lorundrostat. Mineralys Therapeutics is set for a pre-filing meeting with the FDA in the fourth quarter to discuss its submissions based on recent clinical achievements. In addition, Boehringer Ingelheim is developing vicadrostat, another aldosterone synthase inhibitor, currently in phase 3 trials but focused on treating chronic kidney disease and heart failure.
As AstraZeneca advances toward regulatory approval, the market will closely monitor the detailed results of the Bax24 trial, which may significantly impact the future landscape of hypertension therapies.
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