Mineralys Therapeutics has reported new findings from two key studies of its aldosterone synthase inhibitor lorundrostat at the American Society of Nephrology’s Kidney Week. The data included results from the late-breaking Phase 2 Explore-CKD trial and renewed attention for the Phase 3 Launch-HTN study, which featured in the meeting’s “Best of JAMA and NEJM” session.

The company said the updates reinforce evidence that the therapy may help address uncontrolled hypertension and chronic kidney disease by targeting dysregulated aldosterone signalling. Jon Congleton, chief executive officer of Mineralys Therapeutics, said: “The presentations at ASN Kidney Week demonstrated the breadth and strength of lorundrostat’s clinical program. As previously announced, the compelling results from multiple trials in this program have positioned us well for the planned filing of a New Drug Application to the FDA in the fourth quarter of 2025 or the first quarter of 2026.”

Explore-CKD, which assessed lorundrostat 25 mg once daily added to standard-of-care therapy including SGLT2 inhibitors, met its primary endpoint at week four. The therapy delivered a 9.3 mmHg reduction in automated office systolic blood pressure, equal to a placebo-adjusted reduction of 7.5 mmHg. Investigators also recorded a placebo-adjusted 25.6% fall in urinary albumin-to-creatinine ratio, a marker of kidney protection.

Safety findings indicated that lorundrostat was generally well tolerated. Serious adverse events occurred in two participants on active treatment and none on placebo. Discontinuations due to treatment-emergent adverse events were uncommon and balanced between study arms.

Matthew Weir, director of the division of nephrology at the University of Maryland Medical Center, said: “These results are important because they show that lorundrostat, when added to standard-of-care therapy, reduced both blood pressure and proteinuria in patients with hypertension and chronic kidney disease. The parallel reductions in systolic blood pressure and albuminuria underscore the potential of lorundrostat to improve cardio-renal outcomes in this high-risk population.”

The Phase 3 Launch-HTN trial, already published in JAMA, was highlighted in the meeting’s “Best of” session. Participants with uncontrolled and resistant hypertension experienced a 16.9 mmHg absolute fall in systolic blood pressure at week six (9.1 mmHg placebo-adjusted) and a 19 mmHg reduction at week 12 (11.6 mmHg placebo-adjusted). The response appeared as early as week two.

Manish Saxena, hypertension specialist and clinical co-director at William Harvey Heart Centre, Barts Health NHS Trust and QMUL, said: “Across trials, lorundrostat showed efficacy in diverse and difficult-to-treat patient groups, including those with confirmed uncontrolled and resistant hypertension, chronic kidney disease, obesity, and in Black or African American participants. Launch-HTN results demonstrated that lorundrostat lowers blood pressure with a persistent, clinically meaningful benefit a full 24-hours following administration.”

Mineralys is continuing long-term assessment in the open-label Transform-HTN extension study. The company has also completed enrolment in Explore-OSA, which is evaluating the therapy in people with hypertension and moderate-to-severe obstructive sleep apnoea. Data are expected in early 2026.