secwatch.observer — SEC 8-K summary
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Issuer:     Hepion Pharmaceuticals, Inc. (HEPA)
CIK:        0001583771
Form:       8-K
Filed at:   2023-05-22T23:59:59+00:00
Accession:  0001104659-23-063036
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Hepion Phase 2 ALTITUDE-NASH trial meets primary endpoint with rencofilstat 225 mg improving liver function
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- Phase 2 trial met primary endpoint: 225 mg rencofilstat reduced DSI by 1.62 units (p<0.05) and SHUNT by 2.8% (p<0.05).
- 61% of 225 mg arm achieved ≥2-point DSI improvement (p<0.05); RISK ACE reduced 1.2 events/100 pt-yrs (p<0.001).
- Secondary endpoints: ALT ↓21.6%, AST ↓4.7%, ProC3 ↓9.6%, PIIINP ↓5.6%, ELF score ↓2.5% at 225 mg (all p<0.001).
- Rencofilstat well tolerated; no drug-related SAEs; supports ongoing Phase 2b ASCEND-NASH paired biopsy trial.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1583771/000110465923063036/0001104659-23-063036-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1583771/000110465923063036/tm2316423d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-23-063036

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