- Mineralys Therapeutics (MLYS, Financial) unveils significant results from its Phase 3 Launch-HTN trial for lorundrostat in treating uncontrolled or resistant hypertension.
- Lorundrostat 50mg reduced systolic blood pressure by 16.9 mmHg at Week 6 and 19.0 mmHg at Week 12.
- Only 0.1% of participants experienced treatment-related serious adverse events, indicating a favorable safety profile.
Mineralys Therapeutics, Inc. (MLYS) announced the successful results of its pivotal Phase 3 Launch-HTN trial for lorundrostat, a targeted aldosterone synthase inhibitor aimed at treating uncontrolled or resistant hypertension. The trial, which included over 1,000 participants, demonstrated that lorundrostat 50mg dosed once daily provides a significant reduction in systolic blood pressure.
At Week 6, participants experienced a 16.9 mmHg reduction, while at Week 12, the reduction reached 19.0 mmHg. Both figures were adjusted for placebo, revealing reductions of 9.1 mmHg and 11.7 mmHg respectively, with statistical significance (p
The favorable safety profile of lorundrostat was underscored by a low incidence of treatment-related serious adverse events, reported at just 0.1% among participants. Although some patients experienced hyperkalemia, it was at a manageable rate of 0.6-1.1%.
This trial is notable for being the largest hypertension study to date for an aldosterone synthase inhibitor conducted under real-world conditions. Participants continued with their existing two to five antihypertensive medications, highlighting lorundrostat's potential as an effective add-on therapy.
The Launch-HTN trial follows the successful Advance-HTN trial, further solidifying lorundrostat's positioning for potential FDA approval. These developments mark a promising step forward in hypertension treatment, targeting the dysregulated aldosterone pathway, a key driver of the condition.
