GENFIT announced that it is presenting Phase 1 clinical data evaluating NTZ as part of its Acute- on-Chronic Liver Failure (ACLF) Program at Digestive Disease Week(R), taking place from May 6-9, 2023 in Chicago, Illinois (USA). The Phase 1, open-label clinical study was conducted to evaluate the safety, tolerability and pharmacokinetics (PK) of nitazoxanide (NTZ) in subjects with hepatic impairment (HI), as part of GENFIT's NTZ in ACLF program. NTZ was generally well tolerated, with a favorable safety profile, in subjects with moderate and severe HI.

Preliminary data from a similar Phase 1 study conducted in subjects with renal impairment also support a favorable safety and tolerability profile. Taken together, safety and pharmacokinetic results, as well as exploratory pharmacodynamic data, support further clinical development of NTZ in patients with ACLF. A Phase 2a proof of concept study with NTZ in patients with ACL FDA.

A Phase 2a proof the potential of NTZ in patients with ACF grades 1 and 2 is currently under discussion with the FDA.