Mineralys Therapeutics(US:MLYS)2025-06-17 13:00Summary of Minerals Therapeutics Conference Call Company and Industry - Company: Mineralis Therapeutics - Industry: Pharmaceuticals, specifically focusing on treatments for hypertension and chronic kidney disease (CKD) Key Points and Arguments 1. Positive Clinical Trial Results: The EXPLORER CKD trial demonstrated positive top-line data for lorundrostat, a selective aldosterone synthase inhibitor, in patients with uncontrolled hypertension and CKD [5][22][31] 2. Efficacy of Lorundrostat: The trial showed a clinically meaningful reduction in systolic blood pressure of 7.5 mmHg (p=0.002) and a 30.1% reduction in urinary albumin to creatinine ratio (UACR) (p=0.0001), indicating renal protective properties [15][17][22] 3. Safety Profile: The incidence of hyperkalemia was 12.1%, with only modest changes in mean eGFR observed, suggesting a manageable safety profile for lorundrostat in CKD patients [19][20][22] 4. Patient Population: The study included patients with a mean age of 65, a mean eGFR of 55, and a significant percentage (76%) being diabetic, highlighting the trial's focus on a high-risk population [13][14] 5. Comparison with Other Trials: The results were consistent with previous trials (ADVANCE HTN and LAUNCH HTN), reinforcing the efficacy and safety of lorundrostat across different patient populations [15][31] 6. Regulatory Plans: The company plans to submit a New Drug Application (NDA) to the FDA, incorporating data from the EXPLORER CKD trial, with a pre-NDA meeting anticipated in Q4 2025 [32][53] 7. Future Studies: Ongoing trials (EXPLORER OSA and TRANSFORM HCM) aim to further explore the benefits of lorundrostat in related conditions, including obstructive sleep apnea (OSA) [9][31][66] Other Important Content 1. Mechanism of Action: Lorundrostat works by inhibiting aldosterone production, which may offer advantages over mineralocorticoid receptor antagonists (MRAs) that can lead to rebound increases in aldosterone levels [26][60] 2. Monitoring and Management: Recommendations for potassium monitoring include checking levels 2-3 weeks after starting treatment, with adjustments based on individual patient factors [82][83] 3. Commercial Strategy: The company is seeking partnerships for commercialization, particularly focusing on cardiovascular franchises that align with the drug's potential in treating cardio-metabolic disorders [100][101] 4. Patient Compliance: Emphasis on the importance of tolerability in CKD patients, as side effects can lead to noncompliance with treatment regimens [26][27] This summary encapsulates the critical insights from the conference call, highlighting the advancements in lorundrostat's clinical development and its implications for treating hypertension in CKD patients.