Mineralys Looks To Path Ahead For MLS-101 In Hypertension

The company plans to meet with the FDA before the end of the year to discuss the way forward, including a pivotal study it hopes to launch in 2023 in uncontrolled and resistant hypertension.

Mineralys announced positive topline data from its Phase II study of MLS-101 in hypertension • Source: Shutterstock

With positive topline Phase II data for its aldosterone synthase inhibitor, MLS-101, Mineralys Therapeutics, Inc. is preparing to move forward into the increasingly competitive field of treating patients with hypertension whose condition is uncontrolled or resistant to medication, estimated to affect more than 30 million patients in the US alone.

Mineralys announced 16 November top-line results from the Phase II Target-HTN trial comparing MLS-101 at 50mg or 100mg against placebo. The company said the study met its primary and secondary endpoints, with mean placebo-adjusted reduction in systolic blood pressure of 9.7mmHg in subjects with uncontrolled and resistant hypertension receiving the drug at 50mg (p=0.01 vs. placebo)

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