Mineralys Therapeutics has published significant results from its Phase 3 Launch-HTN trial in the Journal of the American Medical Association, focusing on the treatment of uncontrolled hypertension.

The Launch-HTN trial involved 1,083 participants across 159 clinic sites in 13 countries, conducted from late 2023 to mid-2024, with follow-up until early 2025.

Participants were randomized to receive either 50 mg of lorundrostat daily, with potential escalation to 100 mg, or a placebo for 12 weeks, focusing on changes in systolic blood pressure.

The results showed that lorundrostat achieved statistically significant reductions in systolic blood pressure, with decreases of 16.9 mmHg at Week 6 and 19.0 mmHg at Week 12 compared to placebo.

The treatment demonstrated effectiveness across diverse demographics, including variations in age, sex, race, and body mass index, indicating broad applicability.

Hypertension remains a leading cause of cardiovascular disease, with less than 50% of patients achieving their blood pressure goals despite current treatments, underscoring the need for effective therapies like lorundrostat.

The trial's results are expected to establish lorundrostat as a potential best-in-class treatment for hypertension, particularly for patients who do not respond adequately to existing therapies.

Researchers support the use of lorundrostat as a new treatment option for uncontrolled and treatment-resistant hypertension, as detailed in the study.

The trial demonstrated that lorundrostat was generally well-tolerated, with most treatment-emergent adverse events being mild and transient.

While mild to moderate adverse events were reported, nine participants discontinued due to prespecified adverse events related to kidney function or electrolyte imbalances, but none in the placebo group.

The study's limitations include its short duration of 12 weeks and the use of unattended office blood pressure measurements instead of the preferred ambulatory blood pressure monitoring.

Jon Congleton, CEO of Mineralys Therapeutics, expressed optimism about lorundrostat's potential as a leading treatment for uncontrolled hypertension, noting the urgent need for better blood pressure control globally.