Shares of Mineralys Therapeutics Inc. (MLYS) are up nearly 40% at $21 in premarket trading, following AstraZeneca's (AZN) positive trial results for Baxdrostat, a highly selective aldosterone synthase inhibitor, or ASI, for hypertension. As Mineralys is also developing ASIs targeting hypertension and related cardiorenal conditions, the news has triggered a domino effect, lifting sentiment across the ASI space.
Mineralys' lead drug candidate is Lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) & resistant hypertension (rHTN), chronic kidney disease, and obstructive sleep apnea.
In March of this year, Mineralys announced positive results from its Launch-HTN and Advance-HTN trials.
Launch-HTN is a pivotal phase III trial evaluating the blood pressure-lowering effects of Lorundrostat in adults with uncontrolled hypertension, including treatment-resistant hypertension, who are taking 2-5 antihypertensive medications.
Advance-HTN is a pivotal phase II trial evaluating the blood pressure-lowering effect of Lorundrostat administered on a background of a standardized antihypertensive medication regimen in adults with uncontrolled hypertension, including treatment-resistant hypertension.
According to the trial results, in the Launch-HTN study, a 50 mg dose of Lorundrostat significantly lowered systolic blood pressure by 16.9 mmHg at Week 6. Compared to those who got a placebo, the drop was 9.1 points greater, which is considered highly significant. The study also met its predefined goal, with the 50 mg dose of Lorundrostat lowering systolic blood pressure by 19.0 mmHg at week 12. After adjusting for the placebo effect, the drug showed an 11.7 mmHg greater reduction, a result that was highly statistically significant.
The Advance-HTN study also met its primary endpoint, with the 50 mg dose of Lorundrostat lowering blood pressure by 7.9 mmHg more than placebo.
As for AstraZeneca's Baxdrostat, it met the primary and all secondary endpoints in a phase III trial, dubbed BaxHTN, delivering meaningful and sustained blood pressure reductions in patients with hard-to-control hypertension.
At week 12, the 2 mg dose of Baxdrostat reduced systolic blood pressure by 15.7 mmHg, with a placebo-adjusted reduction of 9.8 mmHg, demonstrating a statistically significant effect. Similarly, the 1 mg dose lowered systolic blood pressure by 14.5 mmHg, with a placebo-adjusted reduction of 8.7 mmHg, also showing meaningful clinical benefit.
AstraZeneca's Baxdrostat and Mineralys' Lorundrostat both belong to the same class of drugs called Aldosterone Synthase Inhibitors.
When we alerted readers to MLYS on February 5, 2025, it was trading at $10.34. In premarket trading today, the stock is up 40% at $21.
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