secwatch.observer — SEC 8-K summary
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Issuer:     Hepion Pharmaceuticals, Inc. (HEPA)
CIK:        0001583771
Form:       8-K
Filed at:   2022-05-27T23:59:59+00:00
Accession:  0001104659-22-065556
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Hepion reports positive Phase 2a AMBITION NASH data; plans three Phase 2/2b trials starting Q3 2022
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- Phase 2a AMBITION NASH trial met primary endpoints: safety, tolerability, PK; no serious adverse events.
- Phase 2b ASCEND-NASH planned: 336 F2/F3 biopsy-proven NASH subjects, 12-month treatment, 3 doses vs placebo.
- Phase 2 ALTITUDE-NASH to assess liver function in 60 F3 NASH subjects using HepQuant SHUNT test, 4-month duration.
- Phase 2a HCC trial (Simon 2-stage) to enroll up to 42 advanced HCC subjects; primary endpoint disease control rate.
- Screening and enrollment for all three studies expected to begin in Q3 2022.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1583771/000110465922065556/0001104659-22-065556-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1583771/000110465922065556/tm2217120d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-22-065556

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