ML5 / Wikimedia Commons / Public domain / Archive blood-pressure equipment illustration, resized
Mineralys Therapeutics said participants taking its experimental blood-pressure medicine lorundrostat maintained a 17.8 mmHg reduction in systolic pressure through 48 weeks, in new long-term results for adults whose hypertension remained difficult to control.
The company’s November 8 release reported that 56% of participants reached systolic pressure below 130 mmHg at Week 48. The findings came from the Transform-HTN open-label extension and were presented at the American Heart Association’s scientific meeting in Chicago.
The 17.8 mmHg reduction was measured from the baseline of the earlier Launch-HTN trial, not against a concurrent placebo group. Participants in the new analysis had already received lorundrostat during the 12-week parent study and then continued for another 36 weeks while taking their existing blood-pressure medicines.
The efficacy analysis included 504 participants. It excluded those assigned to placebo in a separate four-week treatment-withdrawal substudy between Weeks 24 and 28. The safety analysis included 632 people who received at least one dose in the extension; 583, or 92%, completed 48 weeks of follow-up.
Serious adverse events occurred in 27 participants, or 4.3%, with investigators considering two treatment-related. Thirty-seven participants stopped the trial medicine because of an adverse event, including 10 for hyperkalemia. Hyperkalemia requiring a dose reduction, interruption or discontinuation occurred in 32 participants.
The company said potassium levels rose and a measure of kidney filtration declined early in treatment, with both remaining stable through the open-label period. It reported no new clinically relevant safety findings compared with Launch-HTN. The open-label results add information about durability and safety, but the reported blood-pressure change is not a placebo-adjusted treatment effect.
Lorundrostat is designed to reduce production of aldosterone and is being developed for use alongside other hypertension medicines. It remains investigational and is not approved. Mineralys said the FDA is reviewing its application with a target action date of December 22, 2026; that date is not a guarantee of approval.
JBizNews Desk | Radnor, Pennsylvania
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