Zura Bio submits protocol to FDA for Phase 2 study of Tibulizumab

Zura Bio (ZURA) “announced the submission of a protocol to its open Investigational New Drug application with the U.S. Food and Drug Administration for a Phase 2 study evaluating tibulizumab, a humanized tetravalent bispecific dual antagonist antibody designed to neutralize both IL-17A and BAFF, for the treatment of systemic sclerosis in adults. The planned Phase 2 clinical trial, a double-blind, randomized (1:1), placebo-controlled study, is designed to evaluate the safety, tolerability, and efficacy of tibulizumab in approximately 80 participants with early diffuse cutaneous systemic sclerosis (dcSSc). The anticipated study aims to demonstrate improvements in skin and lung symptoms, two primary complications of SSc, and includes an open-label extension. The trial is expected to initiate in Q4 2024, with an Orphan Drug Designation request already submitted to the FDA in the same quarter. Tibulizumab has not received approval from any regulatory authority, and its safety and efficacy for the treatment of SSc have not been established.”