Mineralys completes enrollment for hypertension drug trial

RADNOR, Pa. - Mineralys Therapeutics , Inc. (NASDAQ:MLYS), a biopharmaceutical company specializing in the development of treatments for cardiovascular and kidney diseases, has announced the completion of patient enrollment for its Phase 2 Explore-CKD trial. The company, currently valued at approximately $494 million, has seen its stock decline about 19% year-to-date. According to InvestingPro data, the company maintains a strong liquidity position with cash reserves exceeding debt levels. The study evaluates the efficacy and safety of lorundrostat, a novel drug aimed at treating hypertension in patients with chronic kidney disease (CKD) and albuminuria.

The trial, which includes subjects already receiving stable treatment with an ACE inhibitor or an angiotensin receptor blocker and an SGLT2 inhibitor, aims to assess the blood pressure reduction and safety of lorundrostat. The primary endpoint of the study is the change from baseline in systolic blood pressure at week four, with an exploratory endpoint examining the alteration in urine albumin-to-creatinine ratio. Wall Street appears optimistic about the company’s prospects, with analyst price targets ranging from $26 to $45 per share, significantly above current trading levels.

David Rodman, MD, Chief Medical (TASE:PMCN) Officer of Mineralys Therapeutics, expressed gratitude to the participants and staff involved in the trial and highlighted the significance of this research for patients with poorly controlled hypertension, a major cause of renal failure and cardiovascular events in the United States.

CKD affects over 10% of the global population and is a leading cause of death worldwide, with diabetes and hypertension contributing to approximately two-thirds of cases. Hypertension is a major risk factor for heart disease and stroke and was associated with over 670,000 deaths in the U.S. in 2020 alone.

Lorundrostat, Mineralys’ proprietary oral medication, selectively inhibits aldosterone synthase, potentially offering a new treatment option for patients who do not achieve blood pressure control with current medications. The drug has shown promise in a Phase 2 trial, demonstrating a significant reduction in blood pressure and an approximately 70% decrease in plasma aldosterone concentration in hypertensive subjects.

Mineralys Therapeutics plans to release topline data from the Explore-CKD trial in the second quarter of 2025. This press release statement serves as the source of information for the present article. While the company maintains a healthy current ratio of 8.55, InvestingPro analysis indicates rapid cash burn and expectations of continued losses this year. For deeper insights into Mineralys Therapeutics’ financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers, which includes detailed analysis of the company’s financial metrics, market position, and growth potential.

In other recent news, Mineralys Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial of lorundrostat, a drug aimed at treating patients with moderate-to-severe obstructive sleep apnea and hypertension. This comes on the heels of the company’s recent third-quarter earnings report, which revealed a rise in cash and investments to $263.6 million, despite a net loss of $56.3 million due to increased research and development spending. The company expects to use its current financial resources to sustain operations until 2026.

In other developments, Mineralys Therapeutics has completed enrollment for the Advance-HTN and Launch-HTN trials of lorundrostat. The company’s CEO, Jon Congleton, expressed optimism about the potential of the drug to address cardiovascular risks associated with obstructive sleep apnea. The trials’ results are expected in March and mid-2025, respectively.

Additionally, the company’s upcoming trial will be a placebo-controlled, crossover study, with the primary outcome being the absolute change in the frequency of apnea-hypopnea episodes. The study will recruit approximately 40 subjects across 40 sites, focusing on those who are at least 18 years old with a body mass index (BMI) of 27 kg/m2 or higher. These are among the latest developments in Mineralys Therapeutics’ ongoing efforts to advance their clinical trials and research endeavors.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.