AND FDA CLEARANCE TO ADVANCE VONAFEXOR IN A PHASE 2 CLINICAL TRIAL FOR PATIENTS WITH ALPORT SYNDROME
The Company will initiate a Phase 2 clinical study of Vonafexor in Alport Syndrome – called “ALPESTRIA-1” – in the first half of 2024.
Series C proceeds will fund the Phase 2 study, as well as operations and further R&D through the first half of 2026.
Lyon, France – January 3, 2024 – ENYO Pharma (“ENYO”) announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 clinical study of Vonafexor, a highly selective FXR agonist, for the treatment of Alport Syndrome.
Furthermore, ENYO announced the first closing of a 39 million € Series C equity financing, positioning ENYO as an emerging biotechnology company in the field of renal diseases. The financing will support the Phase 2 Alpestria-1 study and further profiling of Vonafexor in other kidney diseases, such as Autosomal Dominant Polycystic Kidney Disease (ADPKD). The financing was co-led by OrbiMed and Morningside Ventures with participation from other existing investors including AndEra Partners, Bpifrance InnoBio and Bpifrance Large Ventures.