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Mineralys Therapeutics’s oral hypertension therapy, lorundrostat, has met the primary endpoint in two pivotal studies, boosting the company’s stock price.
The Phase III Launch-HTN (NCT06153693) and Phase II Advance-HTN (NCT05769608) trials evaluated the efficacy and safety of lorundrostat in patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN).
The biopharma’s stock, listed on the Nasdaq exchange, rose by 65.59% on the news from a 7 March market close of $10.52 to a 10 March market high of $17.42 (correct as of 11:45am EST).
The Launch-HTN trial met its primary endpoint, demonstrating a 16.9mmHg reduction in systolic blood pressure, and a 9.1mmHg placebo-adjusted reduction, after six weeks. This rose to a 19.0mmHg reduction in systolic blood pressure, and an 11.7mmHg placebo-adjusted reduction, after 12 weeks. The randomised, double-blinded, placebo-controlled trial enrolled patients who failed to achieve their blood pressure goal despite being on two to five antihypertensive medications.
The Advance-HTN trial met its primary endpoint with a 7.9mmHg placebo-adjusted reduction in systolic blood pressure, assessed with 24-hour average blood pressure measurement after 12 weeks in patients treated with 50mg of lorundrostat. The randomised, double-blind, placebo-controlled study evaluated the drug as an add-on therapy to background treatment of two or three antihypertensive medications.
The therapy remained safe and well tolerated in both studies, with Mineralys reporting that 14 patients in the Launch-HTN trial suffered serious adverse events (SAEs). There was also some incidence of hyperkalemia (serum potassium above 6.0mmol/L).
Mineralys Therapeutics CEO Jon Congleton said: “We have now completed three successful clinical trials demonstrating the efficacy, safety and tolerability of lorundrostat and the importance of targeting dysregulated aldosterone. We believe the clinical profile observed for lorundrostat supports the potential regulatory approval of this novel agent and its significant commercial value.”
Further data from the studies will be presented at upcoming medical conferences and in peer-reviewed publications.
The US-headquartered company previously announced positive data from the Phase II Target-HTN study.
Mineralys is also running the Transform-HTN open-label extension trial to allow patients to continue receiving lorundrostat while generating additional safety and efficacy data. According to GlobalData forecasts, sales of lorundrostat could reach $601m in 2030.
GlobalData is the parent company of Clinical Trials Arena.