Radnor, Pa.-based Mineralys Therapeutics Inc., a clinical-stage biopharmaceutical company, on Monday reported positive data from two trials for its orally administered lorundrostat to treat certain hypertension conditions.
“We have now completed three successful clinical trials demonstrating the efficacy, safety, and tolerability of lorundrostat,” said Jon Congleton, CEO of Mineralys Therapeutics. “We believe the clinical profile observed for lorundrostat supports the potential regulatory approval of this novel agent and its significant commercial value.”
Mineralys Therapeutics — which develops medicines to target hypertension, chronic kidney disease, obstructive sleep apnea, and other diseases driven by dysregulated aldosterone — said the positive topline data from its Launch-HTN Phase 3 and Advance-HTN Phase 2 trials successfully show the efficacy and safety of lorundrostat to treat uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).
“The positive results and clinically meaningful reduction in blood pressure observed in the Launch-HTN and Advance-HTN trials show us that lorundrostat has the potential to be a transformative new therapy for the approximately 15 to 20 million patients with uncontrolled hypertension in the United States,” Congleton said.
Both trials achieved statistical significance and were clinically meaningful in their pre-specified primary efficacy endpoints and demonstrated a favorable safety and tolerability profile, the company said.
Specifically, the Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled eligible adults who failed to achieve their blood pressure goal despite being on two to five antihypertensive medications.
“The Launch-HTN study evaluating novel drug lorundrostat is one of the largest blood pressure studies in recent times and demonstrates its benefit in lowering blood pressure and its safety in a diverse group of patients whose hypertension is not well controlled,” said Manish Saxena, a hypertension specialist from Barts Health NHS Trust. “Uncontrolled and resistant hypertension remains a global health concern as it continues to be the leading cause of cardiovascular deaths, heart attacks, and strokes.
“Given today’s announcement, lorundrostat could be a good treatment option for millions of patients with high blood pressure,” Saxena said March 10.
Likewise, the Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 pivotal trial that evaluated the efficacy and safety of lorundrostat for the treatment of confirmed uHTN or rHTN, when used as add-on therapy to an optimized background treatment of two or three antihypertensive medications in adult subjects.
Mineralys plans to provide additional data from these two trials at upcoming medical conferences and in peer-reviewed publications.
“We appreciate the commitment and hard work of the clinical investigators, site staff, the Mineralys and Cleveland Clinic research teams, and especially the trial subjects who volunteered to participate in our program,” said Congleton.