Zura Bio submits Phase 2 protocol for tibulizumab in systemic sclerosis to FDA

Zura Bio Ltd

Protocol submitted to open IND for Phase 2 study of tibulizumab (IL-17A/BAFF dual antagonist) in adults with systemic sclerosis.
Study is double-blind, randomized (1:1), placebo-controlled, targeting ~80 participants with early diffuse cutaneous SSc.
Trial expected to initiate in Q4 2024; Orphan Drug Designation request also submitted to FDA same quarter.
Tibulizumab is investigational; no regulatory approval yet for systemic sclerosis or any indication.
CEO cites significant unmet need as current SSc treatments only target interstitial lung disease component.

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