Data presented at the American College of Cardiology’s 72nd Annual Scientific/World Congress of Cardiology (ACC.23/WCC) demonstrated clinically meaningful blood pressure (BP) reduction with once daily dosing of Lorundrostat, according to Mineralys Therapeutics which reported positive results from its Target-HTN Phase 2 trial. Photo courtesy Getty Images.
March 9, 2023 — Positive results from a Mineralys Therapeutics study, the Target-HTN Phase 2 trial, demonstrated clinically meaningful blood pressure (BP) reduction with once daily dosing of Lorundrostat. The data was presented at the American College of Cardiology’s 72nd Annual Scientific Session Together with the World Congress of Cardiology (ACC.23/WCC), held March 4-6 in New Orleans, LA.
Data presented during ACC.23/WCC, held March 4-6, demonstrated clinically meaningful blood pressure (BP) reduction with once daily dosing of Lorundrostat. In reporting positive results from its Target-HTN Phase 2 trial, Mineralys Therapeutics noted the data suggest that Lorundrostat is the first antihypertensive to show that it is uniquely effective in an obese hypertensive population, specifying that Lorundrostat is a novel, orally-administered, highly-selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension.
The Target-HTN (NCT05001945) trial was a Phase 2 randomized, double-blind, placebo-controlled, dose-ranging, multicenter trial conducted in the U.S. Lead investigator was Luke Laffin, M.D., cardiologist, Cleveland Clinic's Heart, Vascular & Thoracic Institute.
The trial was designed to evaluate the safety, efficacy, and tolerability of orally-administered Lorundrostat on BP for the treatment of uncontrolled and resistant hypertension when used as add-on therapy to stable background treatment of two or more antihypertensive agents in 200 male and female, 18 years or older. Five active doses of Lorundrostat (12.5 mg QD, 50 mg QD, 100 mg QD, 12.5 mg twice daily [BID], and 25 mg BID) were compared to placebo in hypertensive subjects.
New data from the study demonstrated the following outcomes:
- Treatment with Lorundrostat at doses of 50 mg and 100 mg once daily (QD) led to a statistically significant reduction in systolic BP in inadequately controlled hypertensive patients on at least two background antihypertensive medications.
- In pre-specified analysis, hypertensive subjects with a BMI ≥30 kg/m2 demonstrated a statistically significant reduction of placebo-adjusted change in systolic BP of 16.7 mmHg (p=0.002) with 50mg QD and a reduction of 12.3 mmHg (p=0.030) with 100 mg QD in Part 1 of the trial.
- Findings from a pre-specified sub analysis showed Lorundrostat was highly effective and safe at lowering BP in patients with obesity and RAAS dysregulation.
- Current hypertension treatments were developed and introduced several decades ago, when the incidence of obesity was below 20 percent and abnormal aldosterone production affected less than 10 percent of the U.S. population. As noted in a statement released by the company regarding the data, hypertension and related health issues result in an average annual economic burden of about $130 billion annually in the U.S., averaged over 12 years from 2003 to 2014.
The company also presented Phase 1 Lorundrostat data in a poster presentation “First-In-Human Study of Lorundrostat, a Potent and Highly Selective Aldosterone Synthase Inhibitor” during ACC23 Together with the World Congress of Cardiology, ACC23/WCC.
For more information: https://mineralystx.com/