secwatch.observer — SEC 8-K summary
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Issuer:     OnKure Therapeutics, Inc. (OKUR)
CIK:        0001637715
Form:       8-K
Filed at:   2024-12-10T23:59:59+00:00
Accession:  0000950170-24-134757
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

OKI-219 well-tolerated in first human trial; no hyperglycemia, Part 1b combo initiated
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- 17 patients dosed across 300–900 mg BID; no dose interruptions, reductions, or discontinuations.
- Only Grade 1 TRAEs reported (diarrhea, nausea, pruritus); no hyperglycemia observed.
- 900 mg BID achieved steady-state PK with near-continuous EC80 coverage for pAKT inhibition.
- Two HR+/HER2- breast cancer patients on 300 mg showed >7 months stable disease; one had >95% ctDNA reduction.
- Part 1b evaluating OKI-219 + fulvestrant initiated; single-agent/combination data expected 2H 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1637715/000095017024134757/0000950170-24-134757-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1637715/000095017024134757/okur-20241210.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-134757

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