GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today 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®, 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. For the study, subjects between 18 and 75 years of age with HI received repeated oral dose administration of NTZ 500 mg twice a day for 7 days.
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 ACLF grades 1 and 2 is currently under discussion with the FDA.
Dr. Carol Addy, CMO at GENFIT commented:
“We are pleased with the encouraging data and outcome of this Phase 1 study as it supports the potential of NTZ in ACLF and the rationale for further exploration of this drug in this indication. ACLF is an underserved medical condition given its high short-term mortality and that no drugs are currently approved for this indication. We hope that the Phase 2 study, expected to be launched in the second half of 2023, will replicate these encouraging results and support the potential for NTZ as a novel therapeutic option for patients with ACLF.”
ABOUT DIGESTIVE DISEASE WEEK® (DDW)
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 6-9, 2023 in Chicago, Illinois (USA). The meeting showcases more than 3,100 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases characterized by high unmet medical needs. GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades. Thanks to its expertise in bringing early-stage assets with high potential to late development and pre-commercialization stages, today GENFIT boasts a growing and diversified pipeline of innovative therapeutic and diagnostic solutions. GENFIT has facilities in Lille and Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). GENFIT is a publicly traded company listed on the Nasdaq Global Select Market and on compartment B of Euronext’s regulated market in Paris (Nasdaq and Euronext: GNFT). In 2021, IPSEN became one of GENFIT’s largest shareholders and holds 8% of the company’s share capital. www.genfit.com
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