Positive high-level results from the BaxHTN Phase III trial showed baxdrostat at two doses (2mg and 1mg) demonstrated a statistically significant and clinically meaningful reduction in mean seated systolic blood pressure (SBP) compared with placebo at 12 weeks. The trial also successfully met all secondary endpoints. Patients with uncontrolled or treatment resistant hypertension received baxdrostat or placebo on top of standard of care. Baxdrostat was generally well tolerated with a favourable safety profile.

There are 1.3 billion people worldwide living with hypertension. When uncontrolled, hypertension can lead to a higher risk of heart attack, stroke, heart failure and kidney disease. In the US, approximately 50% of hypertensive patients who are on multiple treatments do not have their blood pressure under control. Growing evidence points to aldosterone dysregulation as one of the key biological drivers of hypertension.

Dr. Bryan Williams, Chair of Medicine at University College London, primary investigator, said: “Many people continue to struggle with high blood pressure that is hard to control, even when taking multiple medications. The highly promising BaxHTN Phase III results show that once-daily baxdrostat on top of standard of care can meaningfully lower systolic blood pressure and offer a potential new treatment approach for controlling hypertension, the leading risk factor for cardiovascular disease.”

Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, said: “We are very excited with the BaxHTN Phase III results, which show statistically significant and clinically meaningful reductions in systolic blood pressure. These findings provide compelling evidence of baxdrostat’s potential to address a critical unmet need by targeting aldosterone dysregulation, bringing a novel mechanism to a field that has seen little innovation in over two decades.”

BaxHTN is a Phase III, multicentre, randomised, double-blinded, placebo-controlled, parallel group study to evaluate the safety, tolerability and effect of baxdrostat in patients with uncontrolled hypertension being treated with two different antihypertensive medications and patients with resistant hypertension being treated with three or more different antihypertensive medications, one of which is a diuretic.