AstraZeneca Hypertension Drug Succeeds in Late-Stage Trial
Baxdrostat, acquired in the $1.8B CinCor deal, shows significant blood pressure reduction, paving the way for regulatory submission.
AstraZeneca PLC (NASDAQ: AZN) announced positive results from a pivotal Phase III trial for its novel hypertension drug, Baxdrostat, marking a significant step forward in treating patients with high blood pressure that is resistant to existing therapies.
The Bax24 trial demonstrated that Baxdrostat achieved a statistically significant and clinically meaningful reduction in blood pressure. Patients treated with the drug saw a placebo-adjusted decrease of 14.0 mmHg in 24-hour ambulatory systolic blood pressure after 12 weeks, according to the company's announcement. The results provide crucial validation for AstraZeneca's $1.8 billion acquisition of CinCor Pharma, the company that originally developed the asset.
The successful outcome significantly de-risks the drug and strengthens AstraZeneca's formidable cardiovascular and renal pipeline. Treatment-resistant hypertension, a condition where blood pressure remains high despite the use of three or more antihypertensive medications, represents a major unmet medical need and is associated with a higher risk of stroke, heart attack, and kidney disease.
"These are groundbreaking results," said Dr. Bryan Williams, Chair of Medicine at University College London and the primary investigator for the Bax24 trial, in a statement. He noted that a once-daily Baxdrostat regimen could provide meaningful blood pressure reductions, particularly during the high-risk morning hours. According to AstraZeneca's official press release, the findings build on previous positive data and bolster the case for the drug's efficacy.
The market has reacted favorably to the steady flow of positive data. AstraZeneca's stock, which has a market capitalization of over $262 billion, has been trading near its 52-week high. Following the announcement, the stock saw a notable uptick, rising nearly 11% over five days, as investors digested the news's long-term potential.
Baxdrostat works by inhibiting aldosterone synthase, a key enzyme responsible for producing a hormone that elevates blood pressure. Its durable half-life of up to 30 hours is seen by analysts as a potential competitive advantage over other drugs in development. Sharon Barr, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, highlighted this mechanism as key to the drug's success.
"The substantial improvement in blood pressure observed with Baxdrostat is compelling evidence of its potential to address a critical unmet need by targeting aldosterone dysregulation," Barr stated. The consistent results across multiple late-stage trials strengthen the case for regulatory approval and position the drug as a potential blockbuster.
AstraZeneca acquired Baxdrostat through its purchase of Cincinnati-based CinCor Pharma in early 2023 for approximately $1.3 billion upfront, with the total deal value reaching up to $1.8 billion. At the time, the acquisition was seen as a strategic move to add a differentiated, late-stage asset to its cardiorenal portfolio. The success of the Bax24 trial serves as a powerful validation of that M&A strategy.
The company is now preparing for regulatory submissions with global health authorities, including the U.S. Food and Drug Administration (FDA). Further details from the trial will be presented at the upcoming American Heart Association Scientific Sessions in November, an event closely watched by clinicians and investors. With a strong safety and efficacy profile, Baxdrostat is well-positioned to become a new standard of care for one of the most challenging-to-treat patient populations in cardiovascular medicine.