Reduce liver fat levels and improve kidney function NASH therapy reaches the primary phase 2 clinical endpoint

Today, ENYO Pharma announced that its farnesol X receptor (FXR) agonist vonafexor has reached key primary and secondary endpoints in a Phase 2a clinical trial for the treatment of patients with F2-F3 non-alcoholic steatohepatitis (NASH)

NASH is a liver disease characterized by excessive liver fat, balloon-like lesions, inflammation, and fibrosis

Vonafexor is a synthetic non-steroidal, non-bile acid, highly selective FXR agonist.

FXR activation is beneficial to liver growth and regeneration, and has been proven to prevent and eliminate liver fibrosis and steatosis in rodents and humans

In this phase 2a trial, 96 NASH patients were randomized to take vonafexor (200 mg or 100 mg) or placebo once a day at a ratio of 1:1:1

Compared with baseline, vonafexor treatment significantly improved eGFR by an average of 5.

In addition, vonafexor also improves γ-glutamyltransferase (GGT) and alanine aminotransferase (ALT) levels

In terms of safety, as with other FXR agonists, itching is observed in patients treated with vonafexor, and the symptoms are usually local, temporary, and mild

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Reference materials:

[1] ENYO Pharma Announces Positive Vonafexor (EYP001) Results for the LIVIFY Phase 2a Study in F2-F3 NASH Patients over 12 weeks.