Zura Bio Begins Global Phase 2 TibuSURE Study on Tibulizumab for Systemic Sclerosis

HENDERSON, NV, USA I December 23, 2024 I Zura Bio Limited, a clinical-stage immunology company, has initiated TibuSURE, a Phase 2 global study of tibulizumab, aimed at treating systemic sclerosis (SSc) in adults. Zura Bio specializes in developing innovative dual-pathway antibodies for autoimmune and inflammatory diseases.

Systemic sclerosis is an autoimmune disease that is particularly challenging, characterized by inflammation and fibrosis, affecting both skin and internal organs. Effective treatments are scarce, and the disease is known for its complexity and life-threatening potential. Symptoms often include skin thickening, extreme sensitivity to cold, muscle numbness, joint stiffness, and fibrosis in the lungs and heart. Other affected areas may include the gastrointestinal tract, leading to digestive issues and kidney dysfunction. Currently, treatment options for systemic sclerosis are very limited, with only a couple of therapies approved for severe lung complications in the United States.

Tibulizumab presents a dual-pathway approach, targeting both inflammation and fibrosis simultaneously. Kiran Nistala, Chief Medical Officer of Zura Bio, highlighted that this novel approach might offer superior benefits compared to single-pathway treatments, which have shown limited success in rheumatic conditions like systemic sclerosis. Christopher Denton, a Professor of Experimental Rheumatology, emphasized the innovative potential of tibulizumab in addressing the complex pathology of systemic sclerosis by targeting two pivotal biological pathways.

The TibuSURE study is designed as a double-blind, placebo-controlled trial that will assess the safety, tolerability, and efficacy of tibulizumab in approximately 80 participants with early diffuse cutaneous systemic sclerosis. The study will span over a 24-week efficacy assessment and include a 28-week open-label extension. The primary measure of effectiveness will be the modified Rodnan Skin Score (mRSS), which evaluates skin thickening. Secondary measures will include lung function assessed via quantitative high-resolution computed tomography (qHRCT) and forced vital capacity (FVC), as well as physical function and a combined response index specific to systemic sclerosis.

Tibulizumab is an investigational humanized, tetravalent bispecific antibody that combines features of Taltz® and tabalumab. It is engineered to neutralize two key factors involved in inflammation and immune response: IL-17A and BAFF. This novel antibody is also being prepared for Phase 2 clinical trials in the treatment of hidradenitis suppurativa, expected to begin in the second quarter of 2025. Prior studies have tested tibulizumab in conditions such as Sjögren’s syndrome and rheumatoid arthritis.

Zura Bio is committed to advancing its therapeutic assets, including tibulizumab, crebankitug, and torudokimab, through clinical development. These assets aim to demonstrate effectiveness, safety, and dosing convenience for various autoimmune and inflammatory diseases. The initiation of the TibuSURE study is a significant step in Zura Bio's mission to address unmet medical needs in immune-mediated conditions.