Mineralys Therapeutics

Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing targeted treatments for diseases driven by dysregulated aldosterone, a hormone that regulates blood pressure. Founded in 2019 by Catalys Pacific, the company operates from Radnor, Pennsylvania. In 2020, Mineralys licensed its sole product candidate, lorundrostat (formerly MLS-101), from Mitsubishi Tanabe Pharma Corporation, which had conducted initial discovery and Phase 1 trials. The company is led by CEO Jon Congleton, an industry veteran with 35 years of experience in pharmaceuticals, including leadership roles at Teva Pharmaceuticals, Nivalis Therapeutics, and Impel NeuroPharma.

The company's business model is centered on the clinical development and eventual commercialization of lorundrostat. Mineralys has successfully navigated several funding stages, including a $40 million Series A in April 2021, a $118 million Series B in June 2022, and a significant $192 million initial public offering (IPO) in February 2023, listing on the NASDAQ under the ticker "MLYS". The capital raised is being used to fund extensive clinical trials, manufacturing, and pre-commercialization activities. Mineralys targets a substantial market, as dysregulated aldosterone is a key factor in conditions like uncontrolled hypertension (uHTN), resistant hypertension (rHTN), chronic kidney disease (CKD), and obstructive sleep apnea (OSA). The addressable market for these therapies is estimated to potentially exceed $200 billion by 2030.

Lorundrostat is a proprietary, oral, highly selective aldosterone synthase inhibitor. Its mechanism of action is to block the CYP11B2 enzyme, which is responsible for the final step in aldosterone production. This approach aims to reduce aldosterone levels directly at the source, thereby lowering blood pressure and mitigating organ damage, without significantly affecting cortisol levels. This high selectivity (a 374-fold preference for inhibiting aldosterone synthesis over cortisol synthesis) is a key differentiator from older, non-selective mineralocorticoid receptor antagonists (MRAs) like spironolactone, which can cause undesirable side effects. Clinical trials have consistently demonstrated lorundrostat's efficacy. The Phase 3 Launch-HTN trial, one of the largest involving an aldosterone synthase inhibitor, showed that a 50 mg daily dose resulted in a statistically significant and sustained reduction in systolic blood pressure. The drug has also shown a favorable safety and tolerability profile across multiple studies, with modest and reversible effects on electrolytes. Further studies are evaluating its potential in patients with CKD and OSA, which could significantly expand its application.

Keywords: Mineralys Therapeutics, lorundrostat, aldosterone synthase inhibitor, hypertension treatment, resistant hypertension, chronic kidney disease, cardiorenal, dysregulated aldosterone, clinical-stage biopharmaceutical, Jon Congleton, Catalys Pacific, MLYS, blood pressure medication, CYP11B2, Phase 3 trial, obstructive sleep apnea, endocrinology, pharmaceutical development, targeted therapy, cardiovascular disease