GENFIT announced that G1090N - a small molecule and the Company's lead investigational drug candidate for Acute-On-Chronic Liver Failure (ACLF) - demonstrated a favorable Phase 1 safety profile, and a strong anti-inflammatory activity in ex-vivo studies. The Phase 1, open-label trial assessed the safety, tolerability and pharmacokinetics (PK) of G1090N in healthy volunteers following a Single Ascending Dose administration (SAD) phase, and a Multiple Ascending Dose administration (MAD) phase. 13 healthy volunteers were enrolled in each segment, with a total of 76 participants.
G1090N's safety profile observed in healthy volunteers supports continued evaluation. G1090N demonstrated robust biological activity in peripheral blood mononuclear cells (PBMC) assays from healthy volunteers using blood samples from Phase 1 study participants, on LPS-induced IL-6 and TNFa cytokines production, with up to 76% statistically significant inhibition (p1 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo®?.
