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GENFIT: Favorable Phase 1 Safety Profile and Strong Anti-Inflammatory Activity for ACLF Lead Asset G1090N
Phase 1 results confirm investigational drug-candidate G1090N has a favorable safety and tolerability profile, supporting further clinical evaluationCompelling anti-inflammatory activity of G1090N was evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors, showing inhibition of pro-inflammatory pathwayFindings provide a solid foundation for advancing G1090N into Phase 2 proof-of-concept studies across the ACLF continuum Lille (France), Cambridge
About this update from Genfit Sa
[{"type":"list","items":[{"val":[{"type":"text","content":"Phase 1 results confirm investigational drug-candidate G1090N has a favorable safety and tolerability profile, supporting further clinical evaluation","length":149,"tagName":"p"}]},{"val":[{"type":"text","content":"Compelling anti-inflammatory activity of G1090N was evidenced through functional ex vivo assays on blood samples from study participants and cirrhotic donors, showing inhibition of pro-inflammatory pathway","length":205,"tagName":"p"}]},{"val":[{"type":"text","content":"Findings provide a solid foundation for advancing G1090N into Phase 2 proof-of-concept studies across the ACLF continuum","length":120,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":474,"olType":false},{"type":"text","content":"Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), January 6, 2026 - GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today 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.","length":496,"tagName":"p"},{"type":"text","content":"Dr. Jacqueline O’Leary, MD at the UT Southwestern Medical Center, Dallas, TX (USA), commented: “The safety profile observed in Phase 1 and the consistent biological activity evidenced in ex vivo assays represent a meaningful step in development. These findings position G1090N as a promising candidate for patients with acute decompensation and for patients with ACLF, a life-threatening condition with no approved therapies and significant unmet medical need. We are eager to see more patient data as the program moves forward, to confirm G1090N’s safety and strengthen the case for its activity in patients with organ failure.”","length":629,"tagName":"p"},{"type":"text","content":"Phase 1 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 ...