Mineralys Reports Positive Phase 2 Trial Results for Lorundrostat in CKD Hypertensive Patients

Mineralys Therapeutics, Inc., a biopharmaceutical company based in Radnor, Pennsylvania, has revealed promising results from its Phase 2 clinical trial, Explore-CKD, which assessed the safety and effectiveness of lorundrostat in individuals with hypertension and chronic kidney disease (CKD). This trial highlighted significant improvements in systolic blood pressure and urine albumin-to-creatinine ratio, alongside a commendable safety profile.

The Explore-CKD trial was a meticulously designed crossover study, focusing on the impact of lorundrostat, a 25 mg once-daily dose, in managing hypertension in patients with CKD. Key results showed a reduction of 9.3 mmHg in systolic blood pressure, representing a 7.5 mmHg difference when compared to placebo. Moreover, lorundrostat led to a 31% decrease in urine albumin-to-creatinine ratio, indicating its potential in protecting kidney function.

Jon Congleton, CEO of Mineralys, emphasized the significance of lorundrostat in reducing systolic blood pressure and proteinuria among patients with renal impairments. He pointed out the comprehensive clinical profile of lorundrostat, which has been supported by previous successful trials, including Launch-HTN and Advance-HTN.

The trial involved CKD patients who were on background treatments such as sodium-glucose cotransporter 2 (SGLT2) inhibitors and either an angiotensin-converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB). The safety data was robust, with few treatment-emergent adverse events leading to discontinuation. Notably, during the lorundrostat treatment phase, two serious adverse events were recorded, but these were not observed during the placebo phase. Hyperkalemia was reported in a small percentage during the lorundrostat treatment phase.

Lorundrostat’s mechanism involves being an aldosterone synthase inhibitor, which targets dysregulated aldosterone—a critical factor in both hypertension and CKD. By inhibiting aldosterone production, lorundrostat contributes to reducing uncontrolled blood pressure and kidney damage. The reduction in systolic blood pressure and UACR substantiates its potential as a renal protective agent.

Dr. Matthew Weir from the University of Maryland Medical Center praised lorundrostat’s unique mechanism of action and its benefits in managing hypertension and related kidney disorders. The study’s findings align with emerging evidence on the efficacy of aldosterone synthase inhibitors in addressing hypertension's root causes, particularly in patients with concurrent CKD.

Mineralys Therapeutics continues to study lorundrostat’s long-term effectiveness in ongoing trials, including the Transform-HTN extension study. This research aims to further solidify the drug’s safety and efficacy in treating various cardiorenal conditions influenced by aldosterone dysregulation.

Lorundrostat’s development has been backed by four successful clinical trials, emphasizing its efficacy in reducing blood pressure, particularly in participants with uncontrolled and resistant hypertension. Through ongoing trials, Mineralys is committed to advancing lorundrostat as a promising therapeutic solution for patients suffering from hypertension, CKD, and obstructive sleep apnea.

The Explore-CKD trial underscores a significant advancement in the treatment of hypertension and CKD, offering hope for improved management of these interlinked conditions. As Mineralys Therapeutics continues its research, lorundrostat stands as a promising candidate to address the underlying mechanisms of these diseases, potentially enhancing patient outcomes and quality of life.