Pipeline
About tibulizumab
tibulizumab
Tibulizumab (ZB-106) is a potential first-in-class anti-IL-17 and anti-BAFF dual antagonist engineered through the fusion of tabalumab with the scFv domains of Taltz® (ixekizumab), enabling the neutralization of both IL-17A and BAFF within a single molecule.
Study participants have been dosed with tibulizumab across three Phase 1b studies, including two completed studies in rheumatoid arthritis and Sjögren’s syndrome. Based on findings from participants treated to date, the safety profile appears acceptable, with no new findings relative to known IL-17 and BAFF inhibitors. Chronic toxicology studies have been completed with no drug-related adverse findings.
Tibulizumab is now advancing through Phase 2 development, with recruitment completed in TibuSHIELD, a study in hidradenitis suppurativa and TibuSURE, a study in systemic sclerosis. A third Phase 2 trial, NEXUS-PMR, is planned to initiate by year end 2026 for polymyalgia rheumatica.
Anti IL-17 / BAFF (BAFF + 17)
Tibulizumab disrupts IL-17 and/or BAFF-Mediated Inflammation
Tibulizumab has the potential to treat diseases driven by B-cell and T-cell signalings
T-cell and B-cell synergy
Multiple T-cell driven diseases remain sub-optimally treated despite the growth in “pure play” anti-IL-17A drugs
B-cell driven diseases often have a T-cell driven autoimmune component contributing to the pathology
Combined approach to address T-cell and B-cell drivers of autoimmunity has the potential to increase clinical benefit
HIDRADENITIS SUPPURATIVA
Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease estimated to affect more than 1 million people in the U.S.
Despite advances in treatment, many patients continue to experience recurrent flares, ongoing pain, and progressive tissue damage. As a result, there remains a need for additional therapies that can provide more effective and durable disease control.
Tibulizumab is an investigational dual-antibody that targets IL-17 and BAFF, two pathways believed to play a role in the inflammatory and immune processes associated with HS. By targeting these complementary pathways, tibulizumab is being evaluated for its potential to modulate disease-related inflammation. If approved, tibulizumab may provide a novel therapeutic approach for people living with HS. Its once-monthly subcutaneous dosing regimen may offer a convenient administration schedule for patients and healthcare providers.
SYSTEMIC SCLEROSIS
Systemic sclerosis (SSc) is a rare autoimmune disease characterized by inflammation, fibrosis, and vascular abnormalities that can affect multiple organ systems. Approximately 300,000 individuals are affected across the U.S., E.U., and Japan.
Significant unmet need remains in systemic sclerosis, with limited treatment options available. While therapies are approved for systemic sclerosis-associated interstitial lung disease (SSc-ILD), few treatments address the broader manifestations of the disease.
Tibulizumab’s dual-targeting approach is designed to inhibit IL-17 and BAFF, pathways believed to contribute to the inflammatory and autoimmune processes associated with systemic sclerosis. This investigational therapy is being evaluated for its potential to modulate biological pathways relevant to the disease. If approved, tibulizumab may help expand treatment options for patients living with SSc. Its once-monthly subcutaneous dosing regimen may offer a convenient treatment schedule for long-term disease management.
DOWNLOAD THE SYSTEMIC SCLEROSIS (SSc) DISEASE STATE FACT SHEET
POLYMYALGIA RHEUMATICA
Polymyalgia rheumatica (PMR) is an inflammatory disease that causes pain and stiffness, primarily affecting the shoulders, neck, and hips. It occurs most commonly in adults over the age of 50, with incidence increasing with age, and affects more than 700,000 people in the U.S.
Treatment options for PMR remain limited. Corticosteroids are the current standard of care, and many patients require prolonged treatment, which may lead to cumulative corticosteroid exposure and an increased risk of treatment-related side effects. Only one FDA-approved biologic therapy is currently available for patients who have an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
By targeting IL-17 and BAFF, tibulizumab is being investigated for its potential to modulate complementary inflammatory and immune pathways relevant to PMR. Planned studies will evaluate whether this approach could provide an additional treatment option for patients with limited alternatives. If approved, once-monthly subcutaneous administration may help reduce treatment burden and provide a convenient treatment option for patients seeking alternatives to long-term corticosteroid therapy.
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