HENDERSON, Nev. / Nov 14, 2024 / Business Wire / Zura Bio Limited (Nasdaq: ZURA) (“Zura Bio”), a clinical stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, today announced the submission of a protocol to its open Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) 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 (SSc) in adults.

“Systemic sclerosis presents significant unmet needs, as current treatments largely target only its interstitial lung disease (ILD) component,” said Robert Lisicki, CEO of Zura Bio. “Tibulizumab, with dual IL-17A and BAFF inhibition, offers a potential first-in-class approach addressing both immune dysregulation and fibrosis—key drivers of the disease. This study protocol reflects our commitment to advancing therapies that could potentially bring meaningful improvements for those affected by systemic sclerosis.”

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.

ABOUT SYSTEMIC SCLEROSIS

Systemic sclerosis (SSc), also known as scleroderma, is a rare, life-threatening autoimmune disease affecting approximately 300,000 individuals worldwide, including around 100,000 in the United States. Characterized by chronic inflammation and progressive fibrosis of connective tissues, SSc primarily affects the skin and lungs but can also impact the heart, liver, kidneys, digestive tract, and vascular system. The most common symptoms of SSc include skin thickening and extreme sensitivity to cold in the extremities. The disease can also affect other organs and tissues, leading to muscle numbness and swelling, joint stiffness and reduced mobility, fibrosis in the lungs and heart, kidney dysfunction, and gastrointestinal issues such as difficulty swallowing, heartburn, bloating, constipation, and diarrhea.

There remains a high unmet medical need due to the limited treatment options available for individuals living with SSc. Currently, only two disease-modifying therapies are FDA-approved for severe lung complications of the disease (i.e., SSc-ILD), and no effective treatment exists that addresses the disease across multiple organ systems.

ABOUT TIBULIZUMAB

Tibulizumab, an investigational humanized, tetravalent bispecific dual-antagonist antibody, is a fusion of Taltz® (ixekizumab) and tabalumab, engineered to bind to and neutralize both IL-17A and BAFF. Tibulizumab is expected to enter Phase 2 clinical development for the treatment of systemic sclerosis in Q4 2024 and for the treatment of hidradenitis suppurativa in Q2 2025. Before in-licensing, Phase 1/1b studies of tibulizumab were conducted in Sjögren’s syndrome and rheumatoid arthritis.

ABOUT ZURA BIO

Zura Bio is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases. Currently, Zura Bio is developing three assets which have completed Phase 1/1b studies. The company is developing a portfolio of therapeutic indications for tibulizumab (ZB-106), crebankitug (ZB-168), and torudokimab (ZB-880), with a goal of demonstrating their efficacy, safety, and dosing convenience in autoimmune and inflammatory diseases, including systemic sclerosis and other novel indications with unmet needs.

FORWARD-LOOKING STATEMENTS

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