Mineralys expands lorundrostat Phase 2 trial to include SGLT2i combo for CKD, start H2 2023

Mineralys Therapeutics, Inc.

Two-part Phase 2 trial: Part A (proof-of-concept) up to 100 subjects with mild-moderate CKD; Part B (safety) up to 20 subjects with moderate-severe CKD.
Part A tests lorundrostat 50mg alone and in combination with dapagliflozin 10mg vs placebo over 12+12 weeks.
Part B is open-label dose escalation (25mg to 50mg) in renally compromised patients (eGFR 25-44).
Topline data expected between Q4 2024 and Q1 2025.
Program builds on aldosterone's role in CKD progression and positive Target-HTN trial results.

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