Hypertension affects one in three adults globally and is the leading modifiable risk factor for cardiovascular disease. Aldosterone dysregulation, often driven by obesity and primary aldosteronism, affects up to 30% of patients with hypertension, many of whom are undiagnosed or untreated.
The Launch-HTN study, published in JAMA, evaluated the efficacy and safety of lorundrostat in 1,083 participants with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) who were taking two to five antihypertensive medications.
Results showed that when added to existing background treatment, lorundrostat was shown to be a safe and effective treatment for people with uncontrolled or resistant hypertension, demonstrating consistent blood pressure reductions across a large and diverse patient population. It is the largest phase three trial of an aldosterone synthase inhibitor for the treatment of hypertension.
The results are a major milestone toward delivering the first targeted aldosterone synthase inhibitor treatment for uncontrolled or resistant hypertension, which could benefit millions of people affected by the conditions.
Dr Manish Saxena, Clinical Co-Director of Queen Mary University of London's William Harvey Heart Centre and Hypertension Specialist at Barts Health NHS Trust, is the study's lead investigator. He said: "Despite available treatments, more than 40% of adults with hypertension worldwide are not reaching their blood pressure goal. There's a major need to explore novel therapies for hypertension and the Launch-HTN trial addressed this need.
"Aldosterone pathway plays important role in blood pressure regulation, and leads to blood pressure related complications such as heart failure and kidney problems. In the Launch-HTN trial, we explored the safety and effectiveness of lorundostat, which belongs to a new class of drugs called aldosterone synthase inhibitors that block production of hormone aldosterone from the adrenal glands.
"The Launch-HTN trial is the largest phase 3 hypertension study with a novel drug. We tested lorundostat in a large, diverse patient population recruited globally, and found that it has a good safety profile and lowered blood pressure consistently in our patient groups. Once commercially available, lorundostat could be novel treatment option for hypertension in millions of patients worldwide."
Launch-HTN was funded and supported by Mineralys Therapeutics.
