Hepion Pharma's NASH Candidate Aces Mid-Stage Study

Hepion Pharmaceuticals Inc HEPA has announced positive topline results from its Phase 2a AMBITION NASH clinical trial evaluating CRV431, a potent inhibitor of cyclophilins.
In the trial, CRV431 blood concentrations after oral dosing of either 75 mg or 225 mg once daily were in the anticipated effective range for NASH treatment.
The drug reached maximum concentrations within two hours after dosing with an effective half-life of approximately 30 hours, supporting once-daily dosing.
The primary outcome measure of the AMBITION trial was the incidence of safety and tolerability events of CRV431 versus placebo. CRV431 at both study doses was well tolerated, and there were no serious adverse events ("SAEs"). The few adverse events observed were primarily mild and unrelated to the study drug.
The percent serum alanine aminotransferase (ALT) change from baseline to Day 28 numerically demonstrated a CRV431 versus placebo dose-response.
ALT is an enzyme found mainly in the cells of the liver and kidney. Usually, ALT levels in the blood are low, but higher ALT levels indicate liver damage.
These declines were statistically significant from placebo (p < 0.05) when CRV431 doses were pooled.
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