Key Takeaways AZN's baxdrostat met all primary and secondary endpoints in a phase III study for uncontrolled hypertension. Both 1 mg and 2 mg doses showed significant SBP reductions and were well-tolerated over 12 weeks. AZN got baxdrostat via CinCor acquisition; late-stage studies for additional indications are also underway.AstraZeneca (AZN) reported positive top-line results from a late-stage study evaluating the safety, tolerability and efficacy of its investigational candidate, baxdrostat, in patient ...

Core Insights - Mineralys Therapeutics announced positive topline data from its Phase 2 Explore-CKD trial, demonstrating the efficacy and safety of lorundrostat in treating hypertension and chronic kidney disease (CKD) [1][2][3] Efficacy, Safety and Tolerability Results - The Explore-CKD trial was a randomized, double-blind, placebo-controlled crossover trial involving 59 subjects, focusing on the efficacy of 25 mg lorundrostat in reducing systolic blood pressure (BP) and urine albumin-to-creatinine ratio (UACR) [4][13] - Lorundrostat achieved a 9.3 mmHg reduction in systolic BP and a 31% reduction in UACR, both statistically significant [7][5] - The trial showed a favorable safety profile, with treatment-emergent adverse events (TEAEs) leading to discontinuation in 3% of subjects during lorundrostat treatment [8][9] Clinical Significance - The trial results support the potential of lorundrostat as a treatment option for patients with hypertension and comorbid CKD, addressing the underlying mechanisms of these conditions [10][11] - The findings contribute to a growing body of evidence validating aldosterone synthase inhibitors in managing hypertension and CKD [10][18] Future Development - Mineralys plans to submit a New Drug Application (NDA) based on the successful outcomes of the Explore-CKD trial, along with previous pivotal trials [2][18] - Ongoing studies, including the Transform-HTN extension trial and the Explore-OSA trial, aim to further evaluate the long-term efficacy and safety of lorundrostat [11][19]

Core Insights - The Launch-HTN trial demonstrated the efficacy of lorundrostat in reducing systolic blood pressure in over 1,000 participants with uncontrolled or resistant hypertension [1][2][3] - Lorundrostat 50 mg once daily resulted in a 16.9 mmHg reduction at Week 6 and a 19.0 mmHg reduction at Week 12, both statistically significant [1][4][5] - The trial showed a favorable safety and tolerability profile for lorundrostat [1][6] Company Overview - Mineralys Therapeutics, Inc. is focused on developing treatments for hypertension, chronic kidney disease, and obstructive sleep apnea driven by dysregulated aldosterone [1][15] - The company aims to deliver the first targeted aldosterone synthase inhibitor to patients suffering from uncontrolled or resistant hypertension [2][15] Trial Details - The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial involving participants on two to five antihypertensive medications [3][12] - The trial utilized automated office blood pressure measurement to reflect real-world clinical settings [3][12] - Results were presented at the 34th European Meeting on Hypertension and Cardiovascular Protection [2] Efficacy Results - At Week 6, lorundrostat showed a -16.9 mmHg absolute change in systolic blood pressure, with a -9.1 mmHg placebo-adjusted change [4] - At Week 12, the absolute change was -19.0 mmHg, with a -11.7 mmHg placebo-adjusted change [4][5] - The trial met its primary endpoint with statistically significant reductions in blood pressure [3][4] Safety Profile - Lorundrostat exhibited a favorable safety profile, with modest and reversible effects on serum electrolytes [6][12] - The incidence of treatment-emergent serious adverse events was low, with only one participant experiencing a treatment-related serious adverse event [12][6] Industry Context - Hypertension is a significant health issue, contributing to over 685,000 deaths in the U.S. in 2022 and resulting in an estimated economic burden of $219 billion in 2019 [8] - Less than 50% of hypertension patients achieve their blood pressure goals with existing medications, highlighting the need for new treatment options [9]

Core Insights - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases related to dysregulated aldosterone [1][5] - The company announced that data from the pivotal Phase 3 Launch-HTN trial for lorundrostat, targeting uncontrolled hypertension (uHTN) and resistant hypertension (rHTN), will be presented at the 34th European Meeting on Hypertension and Cardiovascular Protection [1][2] Group 1: Lorundrostat Overview - Lorundrostat is an orally administered, highly selective aldosterone synthase inhibitor designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production [3] - It has a 374-fold selectivity for aldosterone-synthase inhibition compared to cortisol-synthase inhibition in vitro, with a half-life of 10-12 hours and a demonstrated 70% reduction in plasma aldosterone concentration in hypertensive subjects [3] Group 2: Clinical Trial Details - The Phase 2 proof-of-concept trial (Target-HTN) showed that once-daily lorundrostat resulted in clinically meaningful blood pressure reduction in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring [4] - Adverse events included a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection, and one serious adverse event of hyponatremia possibly related to the study drug [4] Group 3: Company Background - Mineralys Therapeutics is based in Radnor, Pennsylvania, and was founded by Catalys Pacific, focusing on cardiorenal conditions affected by dysregulated aldosterone [5]

Core Insights - Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases related to dysregulated aldosterone [1][3] - The company will participate in the Bank of America Securities 2025 Health Care Conference from May 12-15, 2025, with a presentation scheduled for May 14, 2025, at 4:35 PM PDT [1][2] Company Overview - Mineralys Therapeutics is developing its initial product candidate, lorundrostat, which is a proprietary, orally administered, highly selective aldosterone synthase inhibitor aimed at treating cardiorenal conditions influenced by dysregulated aldosterone [3] - The company is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [3]