Mineralys Therapeutics has reported outcomes from its pivotal randomised, placebo-controlled Phase III Launch-HTN trial assessing lorundrostat for controlling hypertension.
This global, double-blinded trial involved more than 1,000 subjects having uncontrolled or resistant hypertension (uHTN or rHTN), who were on two to five antihypertensive medications.
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Subjects were randomised and given either a placebo, lorundrostat 50mg once daily, or a dose of lorundrostat 50mg and titrated to 100mg at week six.
Change from baseline in systolic blood pressure against placebo post six weeks of treatment is the primary endpoint of the trial. It was met showing a decrease in placebo-adjusted systolic blood pressure from baseline at week six.
Lorundrostat dosed at 50mg once a day minimised automatised office systolic blood pressure.
At week six, subjects experienced a 16.9 mmHg reduction, with a further decrease to 19 mmHg by week 12, compared to placebo.
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By GlobalDataThe trial’s design reflected real-world clinical settings, using automated office blood pressure (AOBP) measurement and enabling subjects to maintain their current medication regimens.
According to the company, lorundrostat’s tolerability and safety profile was favourable, with modest on-target effects on serum electrolytes, which were quickly reversible upon discontinuation.
Notably, cortisol production suppression was not observed, and there were very few serious adverse events related to the drug that required discontinuation or adjustments of dosage.
Lorundrostat is an oral aldosterone synthase inhibitor targeting the treatment of hypertension, obstructive sleep apnoea, and chronic kidney disease.
Mineralys Therapeutics CEO Jon Congleton said: “The detailed results from Launch-HTN, which was designed to reflect treatment in the real-world setting, mark a pivotal milestone in our mission to deliver the first targeted aldosterone synthase inhibitor to the millions of people suffering from uncontrolled or resistant hypertension.
“With these findings in hand, we now have data from two pivotal trials in distinct-but-complementary populations that reinforce the promise of a new treatment approach for hypertension that directly addresses the dysregulated aldosterone pathway – a key driver of the condition in many patients.”
In March this year, lorundrostat met the primary endpoint in two pivotal trials.
