Mineralys Phase 3 blood pressure pill data support potential FDA approval

Efficacy Results

- Launch-HTN Phase 3 trial met its primary endpoint:

• Lorundrostat 50 mg dose achieved a 16.9 mmHg reduction in systolic blood pressure
• 9.1 mmHg placebo-adjusted reduction (p<0.0001) at week 610

- At week 12:

• 19.0 mmHg reduction in systolic blood pressure
• 11.7 mmHg placebo-adjusted reduction (p<0.0001)10

- Advance-HTN Phase 2 trial also met its primary endpoint:

• 7.9 mmHg placebo-adjusted reduction in 24-hour ambulatory blood pressure monitoring at week 1210

Study Details

• Launch-HTN enrolled 1,083 patients with uncontrolled or resistant hypertension on 2-5 background medications15
• Used automated office blood pressure measurement to reflect real-world clinical settings10
• Patients remained on existing medications10

Safety Profile

• Lorundrostat demonstrated a favorable safety and tolerability profile in both pivotal trials10
• Low rates of serious adverse events11
• Hyperkalemia incidence was 1.1-1.5% in Launch-HTN and 5.3-7.4% in Advance-HTN11

Significance

• Results suggest lorundrostat could be a "transformative new therapy" for approximately 15-20 million patients with uncontrolled hypertension in the US10
• Data from three successful clinical trials now support lorundrostat's efficacy and safety10
• Company believes the clinical profile supports potential FDA approval10

The positive Phase 3 results appear to strongly support Mineralys' plans to pursue FDA approval for lorundrostat as a novel treatment for uncontrolled and resistant hypertension. The company plans to present full results from the Advance-HTN trial at an upcoming medical conference on March 29, 202510.

Sources:

10. https://ir.mineralystx.com/news-events/press-releases/detail/60/mineralys-therapeutics-announces-positive-topline-results

11. https://www.stocktitan.net/news/MLYS/mineralys-therapeutics-announces-positive-topline-results-from-yxh2e9y0tb59.html

15. https://www.biopharmadive.com/news/mineralys-lorundrostat-hypertension-study-results/742000/