Baxdrostat Lowers SBP in Patients With Uncontrolled, Resistant Hypertension

Topline data were announced from a phase 3 trial that evaluated baxdrostat in patients with uncontrolled or treatment resistant hypertension. 

Baxdrostat is a highly selective, oral, small molecule designed to inhibit aldosterone synthase, an enzyme responsible for the synthesis of aldosterone in the adrenal gland. By blocking the production of aldosterone, baxdrostat is expected to decrease sodium and water retention, thereby lowering blood pressure. 

The randomized, double-blind, phase 3 BaxHTN trial (ClinicalTrials.gov Identifier: NCT06034743) included 796 adults with uncontrolled hypertension (2 maximum tolerated antihypertensive medications from different classes with 1 being at least a diuretic) or resistant hypertension (≥3 maximum tolerated antihypertensive medications from different classes with at least 1 being a diuretic).

Study participants were randomly assigned 1:1:1 to receive baxdrostat 2mg, baxdrostat 1mg, or placebo once daily on top of current standard of care therapy. The primary endpoint was the difference in mean change from baseline in seated systolic blood pressure (SBP) at week 12. 

Findings showed baxdrostat at both doses demonstrated a statistically significant and clinically meaningful reduction in mean SBP compared with placebo at week 12. Improvements in secondary efficacy endpoints including seated SBP in the resistant hypertension subpopulation, seated diastolic blood pressure, and achievement of seated SBP less than 130 mmHg were also observed with baxdrostat vs placebo. 

“We are very excited with the BaxHTN phase 3 results, which show statistically significant and clinically meaningful reductions in systolic blood pressure,” said Sharon Barr, Executive Vice President, BioPharmaceuticals R&D. “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.”

The full results from BaxHTN will be presented at the European Society of Cardiology Congress in August.

The BaxHTN study also included a randomized withdrawal period from week 24 to week 32 to assess the persistence of efficacy with baxdrostat 2mg vs placebo on seated SBP. Approximately 300 patients on baxdrostat 2mg were re-randomized 2:1 to either continue on baxdrostat 2mg or placebo. The long-term safety of baxdrostat vs standard of care will be assessed at 52 weeks.