Core Insights - Mineralys Therapeutics has published significant results from the Phase 2 Advance-HTN trial, demonstrating the efficacy of lorundrostat in reducing blood pressure in patients with uncontrolled or resistant hypertension [1][3] - The publication in the New England Journal of Medicine highlights the potential of lorundrostat as a transformative treatment targeting dysregulated aldosterone, a key factor in hypertension [3][10] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea, driven by dysregulated aldosterone [1][10] - The company's lead product, lorundrostat, is a highly selective aldosterone synthase inhibitor designed to lower aldosterone levels and improve blood pressure control [7][10] Clinical Trial Results - The Advance-HTN trial showed that lorundrostat 50 mg resulted in a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction in 24-hour ambulatory blood pressure at week 12 [2][9] - The trial included patients on optimized antihypertensive regimens, demonstrating that lorundrostat is effective regardless of the number of baseline medications [2][3] Safety and Tolerability - Lorundrostat exhibited a favorable safety profile with modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR) [2][3] - Adverse events reported in the trials included a modest increase in serum potassium and a decrease in eGFR, with one serious adverse event of hyponatremia possibly related to the study drug [8][9] Future Developments - Mineralys plans to present additional data from the Phase 3 Launch-HTN trial at an upcoming medical conference and in a peer-reviewed publication [4] - The ongoing Transform-HTN trial will provide further safety and efficacy data as subjects continue to receive lorundrostat [4]

Core Viewpoint - Scienture Holdings, Inc. is preparing for the commercial launch of Arbli, a novel oral liquid formulation of losartan, aimed at addressing unmet needs in the hypertension treatment market, with a targeted launch date in July 2025 [1][5]. Company Overview - Scienture Holdings, Inc. operates as a holding company for pharmaceutical companies focused on developing and distributing specialty products that enhance value for patients and healthcare providers [1][12]. - Scienture, LLC, a wholly owned subsidiary, is responsible for the manufacturing and distribution of Arbli [1][12]. Product Details - Arbli is the first FDA-approved ready-to-use oral liquid formulation of losartan in the U.S., designed for patients over 6 years old, particularly for hypertension and related conditions [2][4]. - The product is available in a 165 mL bottle with a peppermint flavor, has a shelf life of 18 months at room temperature, and does not require refrigeration [6]. Market Context - Losartan, classified as an angiotensin receptor blocker (ARB), is one of the most prescribed medications for hypertension, with annual sales of approximately $292 million and a prescription volume of 68 million in the U.S. market as of December 2024 [4]. - Arbli addresses the limitations of existing losartan products, which are only available in solid forms that require compounding for liquid formulations, thus providing a safer and more convenient option for patients [3][4]. Manufacturing and Distribution - Scienture, LLC has initiated supply chain activities and partnered with Saptalis Pharmaceuticals for the manufacturing of Arbli, ensuring readiness for the planned launch [1][5]. - The company has also established agreements with strategic partners for warehousing and distribution to various wholesalers [1].

Core Insights - Lorundrostat has shown significant efficacy in reducing blood pressure in patients with uncontrolled or resistant hypertension, achieving a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction at week 12 [1][3] - The drug is a highly selective aldosterone synthase inhibitor, targeting aldosterone biosynthesis rather than blocking mineralocorticoid receptors, positioning it as a potential best-in-class treatment for high-risk patients [1][12] - The favorable safety and tolerability profile of lorundrostat, with low discontinuation rates and manageable on-target effects, supports its use in a specialist setting for complex hypertension cases [6][7] Efficacy Results - The Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 trial assessing lorundrostat's efficacy as an add-on therapy to existing antihypertensive medications [3][14] - At week 4, lorundrostat 50 mg demonstrated an 11.5 mmHg absolute change and a 5.3 mmHg placebo-adjusted change in 24-hour average systolic blood pressure [4] - A significant proportion of patients (41%) achieved a 24-hour average systolic blood pressure of less than 125 mmHg at week 4 compared to 18% on placebo [5] Safety and Tolerability Results - Lorundrostat exhibited a favorable safety profile with modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR), and a low incidence of serious adverse events [6][10] - The incidence of hyperkalemia was confirmed at 2.1% and 3.2% for the 50 mg and 50 to 100 mg doses, respectively, after excluding spurious results [10] - The study population included a high proportion of historically underrepresented individuals, with 40% women and 53% Black patients, highlighting the drug's potential impact on diverse demographics [7] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea driven by dysregulated aldosterone [15] - The company plans to present additional data from the pivotal Phase 3 Launch-HTN trial at upcoming medical conferences and in peer-reviewed publications [7] - Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific, emphasizing its commitment to addressing significant unmet needs in hypertension care [15]

Core Insights - Lorundrostat 50 mg achieved a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction in blood pressure at week 12, demonstrating a favorable safety and tolerability profile [1][3] - Lorundrostat is a selective aldosterone synthase inhibitor that targets aldosterone biosynthesis, making it a potential best-in-class treatment for high-risk patients with uncontrolled or resistant hypertension [1][12] - The Advance-HTN trial results support lorundrostat's clinical utility across diverse care settings, addressing a significant unmet need in hypertension management [2][7] Efficacy Results - The Advance-HTN trial was a randomized, double-blind, placebo-controlled Phase 2 trial evaluating lorundrostat's efficacy and safety in patients with uncontrolled or resistant hypertension [3][14] - The primary endpoint was the change in 24-hour average systolic blood pressure (SBP) at week 12, with significant reductions observed [4][14] - Key secondary endpoints included a 7.9 mmHg placebo-adjusted change at week 4, with a notable proportion of patients achieving SBP < 125 mmHg [5][4] Safety and Tolerability - Lorundrostat exhibited a favorable safety profile with modest changes in potassium, sodium, and estimated glomerular filtration rate (eGFR), alongside a low discontinuation rate [6][7] - The incidence of serious adverse events was very low, reinforcing lorundrostat's potential as a well-tolerated therapy for high-risk patients [7][10] - Hyperkalemia incidence was confirmed at 2.1% and 3.2% for the 50 mg and 50 to 100 mg arms, respectively, after validation procedures [10] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea driven by dysregulated aldosterone [15] - The company is based in Radnor, Pennsylvania, and aims to address significant health issues related to hypertension, which has a substantial economic burden in the U.S. [9][15] - Mineralys plans to present additional data from the Phase 3 Launch-HTN trial at upcoming medical conferences [7]

Core Insights - Mineralys Therapeutics announced positive topline data from its pivotal Launch-HTN Phase 3 and Advance-HTN Phase 2 trials for lorundrostat, demonstrating significant efficacy and safety in treating uncontrolled and resistant hypertension [2][3] Efficacy Results - The Launch-HTN trial achieved a 16.9 mmHg reduction in systolic blood pressure at week 6 and a 19.0 mmHg reduction at week 12, with placebo-adjusted reductions of 9.1 mmHg and 11.7 mmHg respectively (p-value < 0.0001) [1][5] - The Advance-HTN trial reported a 7.9 mmHg placebo-adjusted reduction in systolic blood pressure at week 12 [1][6] - Both trials demonstrated clinically meaningful and statistically significant results, supporting the potential of lorundrostat as a new treatment option for approximately 15 to 20 million patients with uncontrolled hypertension in the U.S. [3][4] Safety and Tolerability - Lorundrostat exhibited a favorable safety and tolerability profile across both pivotal trials, with low incidences of serious adverse events and manageable side effects [8][14] - The incidence of hyperkalemia was reported at 1.1% and 1.5% in the Launch-HTN trial and 5.3% and 7.4% in the Advance-HTN trial [14] Future Developments - Full results from the Advance-HTN trial are scheduled to be presented on March 29, 2025, at the American College of Cardiology Scientific Sessions [1][7] - The ongoing Transform-HTN open-label extension trial will continue to gather safety and efficacy data for lorundrostat [10] Company Overview - Mineralys Therapeutics is focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea, with lorundrostat being its lead candidate [2][19] - The company aims to address the significant unmet medical need in hypertension, where less than 50% of patients achieve their blood pressure goals with current medications [12][13]