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Mineralys Therapeutics Announces Expansion of Planned Phase 2 Trial of Lorundrostat Alone and in Combination with SGLT2 Inhibitor to Treat Patients with Chronic Kidney Disease (CKD)
– Plan to initiate a Phase 2 proof of concept trial of lorundrostat alone and in combination with an SGLT2 inhibitor for CKD in the second half of 2023 – –
About this update from Mineralys Therapeutics, Inc.
[{"type":"text","content":"– Plan to initiate a Phase 2 proof of concept trial of lorundrostat alone and in combination with an SGLT2 inhibitor for CKD in the second half of 2023 – – Profiling trial of safety in individuals with stage 3b and 4 CKD to support the hypertension indication will be run in parallel – – The program builds on the established role of aldosterone in the progression of CKD – RADNOR, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced details of an expanded two-part Phase 2 clinical trial for lorundrostat as a potential therapy to treat patients with Stage 2 to 4 chronic kidney disease (CKD), which is expected to start enrolling patients in the second half of 2023. “We are excited to move ahead with this trial to evaluate lorundrostat as a treatment for CKD. This trial builds upon the amelioration of aldosterone-mediated uncontrolled hypertension we observed in our Target-HTN trial of lorundrostat. Over 35 million adults in the U.S. suffer from chronic kidney disease and given the role of aldosterone in CKD, we believe lorundrostat may provide significant clinical benefit,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “This trial will allow us to evaluate the safety, efficacy and tolerability of lorundrostat alone and in combination with an SGLT2 inhibitor in CKD.” “Aldosterone contributes to the development and progression of chronic kidney disease through genomic and non-genomic signaling. The use of lorundrostat, an aldosterone synthase inhibitor or ASI, to inhibit aldosterone production may represent a more complete solution and promising approach to treat CKD patients,” stated David Rodman, M.D. FAHA, Chief Medical Officer of Mineralys Therapeutics. “There is a growing consensus for the use of an SGLT2 inhibitor as a component of CKD treatment. However, for patients with moderate or severe CKD, a high risk of progression to end-stage disease remains. There is reason for optimism that lorundrostat, with an SGLT2 inhibitor, may provide additive clinical benefit, further reducing the rate of CKD progression.” The planned Phase 2 clinical trial will be conducted in two parts, including an initial proof-of-concept portion (P...