---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-24-119079"
form_type: "8-K"
ticker: "ZURA"
cik: "0001855644"
company_name: "Zura Bio Ltd"
filed_at: "2024-11-14T23:59:59+00:00"
generated_at: "2026-05-30T00:37:22.894881+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-24-119079
- form_type: 8-K
- ticker: ZURA
- cik: 0001855644
- company_name: Zura Bio Ltd
- filed_at: 2024-11-14T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1855644/000110465924119079/0001104659-24-119079-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1855644/000110465924119079/tm2428489d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-24-119079
- JSON: https://secwatch.observer/filing/0001104659-24-119079.json
- Plain text: https://secwatch.observer/filing/0001104659-24-119079.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.