Genfit Announces Enrollment Of First Patient In Resolve-It, The Pivotal Phase 3 Clinical Trial Of Elafibranor In Nash

GENFIT

today announced that it has enrolled the first patient in its Phase 3 clinical trial RESOLVE-IT, evaluating Elafibranor as a treatment against NASH. The coordinating Steering Committee members, Professor Vlad Ratziu, Professor of Hepatology Hôpital Pitié Salpêtrière and Université Pierre et Marie Curie Paris, France, COL (Dr.) Stephen Harrison, Hepatologist at Brooke Army Medical Center in San Antonio and Professor of Medicine, Uniformed Services University of the Health Sciences, USA, and Professor Arun Sanyal, Division of Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University School of Medicine, Richmond, VA, USA, commented: "All centers participating to this ultimate phase of clinical development in NASH are excited to see the first patients enrolled so quickly. Despite a large recognition of the unmet need by regulatory agencies and experts alike, our NASH patients still have no approved treatment option today. It is therefore important for all of us to be at the forefront of the research in this field, and to have access to a molecule that has a proven activity against the disease. Elafibranor's pluripotent profile is interesting as it helps to address NASH from a global clinical management perspective, with the potential to improve both liver histology as well as cardiometabolic parameters." Sophie Mégnien, Chief Medical Officer (CMO) of GENFIT Corp., Boston, MA, USA, commented: "We are extremely satisfied by the fast launch of RESOLVE-IT. Having our first patients on-board is an important milestone, and a real performance: it has indeed been only one year since the read-out of Phase 2b. We are proud of the excellent work done by the clinical team, especially on the integration into the Phase 3 protocol of all key adjustments required by the authorities to reflect the new definition of NASH resolution, which we consider a positive development. The enthusiasm from clinical centers worldwide is stronger than ever, particularly following the Gastroenterology publication. We are on track to finalize the recruitment on time."