secwatch.observer — SEC 8-K summary
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Issuer:     Mineralys Therapeutics, Inc. (MLYS)
CIK:        0001933414
Form:       8-K
Filed at:   2023-07-17T23:59:59+00:00
Accession:  0001933414-23-000048
Event type: other_material
Sentiment:  neutral
Materiality: 0.55
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1933414/000193341423000048/0001933414-23-000048-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1933414/000193341423000048/mlys-20230717.htm
  HTML page:      https://secwatch.observer/filing/0001933414-23-000048

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer