Company: ZURA
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001104659-25-110793
Chunk: 10

Company: Zura Bio Ltd
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 2
Chunk 10
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 (ixekizumab) and tabalumab to neutralize interleukin-17A (IL-17A) and B-cell activating factor (“BAFF”). These cytokines play pivotal roles in various inflammatory and autoimmune disorders. By targeting IL-17A and BAFF, tibulizumab demonstrates potential in mitigating chronic inflammation while preserving the integrity of the immune system. Three Phase 1/1b clinical studies evaluating tibulizumab have been completed, including studies involving participants with rheumatoid arthritis and Sjögren’s syndrome.

In May 2025, the Company initiated TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe hidradenitis suppurativa (“HS”). TibuSHIELD is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and efficacy of tibulizumab in approximately 180 adults across the United States, Canada and Europe. The study will evaluate tibulizumab over a 28-week period, which includes a 16-week efficacy assessment period followed by an optional open-label extension (“OLE”) and a 12-week safety follow-up. The primary endpoint of the study is the percent change from baseline in total abscess and nodule (“AN”) count at week 16. Secondary endpoints include the proportion of participants achieving HiSCR50 or HiSCR75, defined as at least a 50% or 75% reduction in AN count without an increase in abscesses or draining fistulas at week 16. Key safety assessments include the assessment of tolerability, and monitoring for adverse events. Topline results are expected to be available in the third quarter of 2026. We continue to monitor timelines and evaluate strategy in light of the competitive landscape for conducting clinical trials, competition for enrollment of patients, and external events, including those potentially impacting regulatory matters and overall study execution.

In December 2024, we initiated TibuSURE, a global Phase 2 clinical study evaluating tibulizumab in adults with early diffuse cutaneous systemic sclerosis (“dcSSc”). TibuSURE is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and efficacy of tibulizumab in approximately 80 participants with early diffuse cutaneous systemic sclerosis (dcSSc). The study includes a 24-week efficacy period followed by a 28-week OLE. The primary endpoint is