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RADNOR, Pa. - Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biotech company with a market capitalization of approximately $894 million, announced positive results from its Phase 3 Launch-HTN trial of lorundrostat, an aldosterone synthase inhibitor for treating uncontrolled or treatment-resistant hypertension. The findings were published Monday in the Journal of the American Medical Association. According to InvestingPro data, five analysts have recently revised their earnings expectations upward, suggesting growing confidence in the company’s potential.
The trial, which included 1,083 participants, showed that lorundrostat 50 mg once daily reduced systolic blood pressure by 16.9 mmHg at week 6 and 19.0 mmHg at week 12 when added to existing treatments. These reductions were statistically significant compared to placebo. While the clinical results are promising, InvestingPro analysis indicates the company is currently burning through cash rapidly, though it maintains a strong balance sheet with cash exceeding debt.
Launch-HTN is described as the largest completed trial of an aldosterone synthase inhibitor in patients with difficult-to-treat hypertension. The study design reflected real-world clinical practice by using automated office blood pressure measurements and allowing participants to continue their existing medications.
Dr. Manish Saxena of Queen Mary University of London’s William Harvey Heart Centre, the lead investigator, noted that dysregulated aldosterone drives hypertension in up to 30% of all hypertensive patients and is a consistent feature of treatment-resistant hypertension.
The drug demonstrated consistent blood pressure-lowering effects across diverse patient groups, including variations in age, sex, race, body mass index, and baseline medication regimens.
Lorundrostat was generally well-tolerated, according to the company’s press release. Treatment-emergent adverse events were mostly mild and transient. The anticipated effects on serum electrolytes were modest and reversible upon discontinuation.
Hypertension remains a significant health concern, with less than 50% of patients achieving their blood pressure goals with currently available medications.
Mineralys Therapeutics is developing lorundrostat for multiple conditions affected by dysregulated aldosterone, including hypertension, chronic kidney disease, and obstructive sleep apnea.
In other recent news, Mineralys Therapeutics has reported positive results from its Phase 2 Explore-CKD trial for lorundrostat, a treatment for hypertension and chronic kidney disease. The trial achieved its primary endpoint with a 7.5 mmHg reduction in systolic blood pressure compared to placebo, and a 25.6% reduction in urine albumin-to-creatinine ratio, a key marker of kidney function. These outcomes are part of a series of successful trials that Mineralys plans to include in a future New Drug Application (NDA). H.C. Wainwright reiterated a Buy rating for Mineralys, highlighting the potential benefits of lorundrostat and its promising safety profile. In contrast, Jefferies initiated coverage with a Hold rating, citing cautious optimism and setting a price target of $15.00. Mineralys is also preparing to present data from its Phase 3 Launch-HTN trial at the upcoming European Meeting on Hypertension and Cardiovascular Protection. This presentation will focus on the efficacy and safety of lorundrostat, which has shown a significant reduction in blood pressure in previous trials. The company plans to meet with the FDA in late 2025 to discuss the regulatory pathway for lorundrostat.
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