other material
confidence high
sentiment positive
materiality 0.85
Hepion reports positive Phase 2a AMBITION NASH data; plans three Phase 2/2b trials starting Q3 2022
Hepion Pharmaceuticals, Inc.
- 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.