US clinical-stage biotech firm, Mineralys Therapeutics, has announced that it has dosed the first patient as part of its trial investigating the treatment of lorundrostat for the treatment of uncontrolled hypertension (uHTN).The Launch-HTN trial (NCT06153693)is the second of two pivotal trials aimed at assessing the safety and efficacy of lorundrostat in combination with other background-prescribed treatments.
The global, randomised, double-blinded, placebo-controlled Phase III trial plans to enrol approximately 1,000 eligible adult participants who are failing to achieve their blood pressure goal on two to five background antihypertensive medications.
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These subjects will then be randomised to one of three arms: placebo, lorundrostat 50 mg once daily (QD), or lorundrostat 50 mg QD and then titrated to 100 mg QD, as needed, at week six. The primary endpoint of the trial is a change from baseline in systolic blood pressure versus placebo after 12 weeks of treatment.
Heart attack and strokes are the leading causes of death in the US. In 2020, with more than 670,000 deaths in the US including hypertension as a primary or contributing cause.
Mineralys Therapeutics says that less than 50% of hypertension patients achieve their blood pressure goal with currently available medications. Abnormally elevated aldosterone levels are a key factor in driving hypertension in approximately 25% of all hypertensive patients.
CEO of Mineralys Therapeutics, Jon Congleton, said, “Initiating this second pivotal trial demonstrates the continued progress we’re making towards introducing a targeted approach to care in hypertension by identifying and profiling potential responders to lorundrostat.”
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By GlobalData“In parallel with our development of lorundrostat, we have been pleased to see accumulating evidence generated by the medical community highlighting aldosterone as a key driver in cardiorenal disease,” he added.
Previously in March of 2023, Mineralys Theraprutics reported positive results from its Phase II clinical trial, Target-HTN (add NCT number here), assessing the efficacy, safety and tolerability of orally administered lorundrostat on blood pressure in hopes of treating hypertension.
Additionally, in May 2023, the company announced the first subject dosed in the first pivotal trial, Advance-HTN (NCT00145925). Topline results from the Advance-HTN trial are expected in the second half of 2024.
