(Photo credits: Genfit -)
(CercleFinance.com) – Genfit announced on Friday that it had made the first visit of the first patient for its Phase 3 clinical study to assess elafibranor in primary biliary cholangitis (PBC), an autoimmune disease that gradually destroys the bile ducts.
This international pivotal trial is expected to shed light on the efficacy and safety of the candidate drug in approximately 150 patients after 52 weeks of treatment.
For Genfit, this is a ‘key step’ in the development of the company.
“We see real potential for elafibranor in the PBC, and we will provide more information on this subject when we present our new strategic direction on September 30,” said its Managing Director Pascal Prigent.
During a screening visit for a phase 3 study, the medical teams explain the conduct of the study in detail to the patient and answer their questions, an interview at the end of which a consent form is signed.
Genfit shares took advantage of these announcements to gain more than 8% on Friday morning on the Paris Bourse.