RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) recently announced positive data from the Target-HTN Phase 2 study that demonstrated clinically meaningful blood pressure reduction with once-daily dosing of lorundrostat at the American College of Cardiology’s 72nd Annual Scientific Session together with the World Congress of Cardiology (ACC.23/WCC) going on now in New Orleans, LA. In a pre-specified analysis, hypertensive subjects with a BMI ≥30 kg/m2, demonstrated a statistically significant reduction of placebo-adjusted change in systolic blood pressure (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 study.
“We continue to be excited by the compelling data from our Target-HTN trial. As detailed in the poster presentation at ACC.23/WCC… the latest subgroup analysis of obese patients further supports our hypothesis of the linkage between obesity, aldosterone and hypertension,” stated Jon Congleton, Chief Executive Officer of Mineralys. “The prevalence of uncontrolled hypertension continues to grow, and with the rate of obesity rapidly rising in tandem, these data underscore our confidence that targeting the underlying cause of hypertension, abnormal aldosterone biology, has the potential to position lorundrostat earlier in the treatment paradigm.”
The data from this sub-analysis of the Phase 2 study were presented in a moderated poster titled, “Highly Effective Blood Pressure Lowering with lorundrostat, a New Aldosterone Synthase Inhibitor, in Individuals with Obesity and RAAS Dysregulation” at the ACC.23/WCC. The poster is available on the Company’s website here.
“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 rates of hypertension and obesity continue to evolve, so must our approach to treatment,” said David Rodman, M.D., Chief Medical Officer of Mineralys. “Our hypothesis when starting Target-HTN was that obesity, abnormal aldosterone biology and hypertension were linked intrinsically. In finding that lorundrostat demonstrated clinically meaningful improvement in obese individuals, we’ve validated our initial thinking, and now have data that will be crucial for developing future trials and bringing lorundrostat to market.”
Initial topline results from the Target-HTN Phase 2 trial demonstrated that 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. Robust placebo-adjusted reductions in systolic BP and diastolic BP were observed in the office, as well as in the home with 24-hour ambulatory blood pressure monitoring demonstrating reduction of 24-hour average systolic BP, night-time systolic BP, and central systolic BP.
“High blood pressure is the world’s leading cause of cardiovascular morbidity and mortality, and the link between elevated nighttime blood pressure and cardiovascular risk is well established in medical literature,” said Luke Laffin, M.D., cardiologist, Cleveland Clinic’s Heart, Vascular & Thoracic Institute, and lead investigator of the Target-HTN trial. “In the Target-HTN trial, we saw statistically significant reductions in overnight blood pressure which is key in controlling hypertension and reducing the risk of morbidity and mortality. These findings are an encouraging demonstration of the potential of lorundrostat to evolve and impact the way in which we treat hypertension as clinicians.”
The Target-HTN (NCT05001945) study was a Phase 2 randomized, double-blind, placebo-controlled, dose-ranging, multicenter trial conducted in the U.S. 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 subjects 18 years of age 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. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one serious adverse event possibly related to study drug being hyponatremia.
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