Mineralys’ shares got a more than 50% boost Monday morning as new data showed its hypertension drug reduced blood pressure in a pair of clinical trials.
Mineralys Therapeutics’ hypertension drug reduced blood pressure in a Phase III trial, sending the biotech’s shares up by more than 50%. But lorundrostat will face a tough market battle, with incumbent Idorsia settling in with a new medicine and several late-stage options coming down the pike.
Lorundrostat is an inhibitor of aldosterone synthase, the enzyme responsible for making the steroid aldosterone. Increased amounts of aldosterone have been often linked to rates of hypertension.
The pivotal Phase III Launch-HTN and Phase II Advance-HTN trials tested lorundrostat in 1,000 patients with uncontrolled high blood pressure who were already taking two to five antihypertensive drugs. The Phase III trial met its primary goal, assessing the change in systolic blood pressure from baseline compared to placebo after six weeks. Patients who received 50 mg of lorundrostat on top of their preexisting regimens saw a 9.1 mmHg placebo-adjusted drop in blood pressure.
Zooming out, at 12 weeks, patients on the lower dose of lorundrostat had an 11.7 mmHg decrease in blood pressure, while patients in the higher dose group had an 8.4 mmHg drop at 12 weeks when adjusted for placebo.
As for safety, 4 patients across the two dosing groups reported adverse events that were deemed related to the treatment. Twelve patients in the 50 mg dose group had events such as increased serum potassium, decreased kidney activity, urinary tract infection and hypertension.
In the Phase II study, patients with uncontrolled or treatment-resistant hypertension on background therapy saw their blood pressure drop by 7.9 with 50 mg of lorundrostat, meeting the main goal of the study. The primary endpoint of blood pressure reduction was measured using a 24-hour average at week 12.
Adverse events were fewer in this study, with two patients reporting AEs, with one report of hyponatremia, which is when sodium levels in the body drop below normal.
Mineralys’ shares rose 52% to $16 per share Monday morning after the results were announced.
“We believe the clinical profile observed for lorundrostat supports the potential regulatory approval of this novel agent and its significant commercial value,” Mineralys CEO Jon Congleton said in a statement. The company plans to announce more detailed findings later this month at the American College of Cardiology Scientific Sessions.
These results continue a positive trend for Mineralys, which in September 2023 announced positive Phase II data from the Target-HTN trial of lorundrostat, also showing improvements in blood pressure.
Monday’s data release also comes after a blizzard of activity in the hypertension space. In March 2024, Idorsia won FDA approval for its hypertension drug Tryvio, an endothelin receptor antagonist, claiming to be the first new mechanism in hypertension treatments in decades. Other companies, including Alnylam and George Medicines, have also announced late-stage anti-hypertension data in the last few months.
