Ixekizumab

HENDERSON, NV, USA I December 23, 2024 I 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 launch of TibuSURE, a Phase 2 global study evaluating tibulizumab for the treatment of systemic sclerosis (SSc) in adults. “Single-pathway inhibition has demonstrated modest effects in rheumatic diseases like SSc. This is why we believe tibulizumab’s dual-pathway approach holds the potential to be best-in-class, aiming to provide deeper efficacy and greater benefits for patients affected by this life-threatening autoimmune disease,” said Kiran Nistala, MBBS, PhD, Chief Medical Officer and Head of Development at Zura Bio. “The initiation of the TibuSURE study marks a significant milestone in addressing certain urgent, unmet needs of this patient population and advancing our mission to improve the lives of those affected by autoimmune and inflammatory conditions.” “Systemic sclerosis is a heterogeneous and complex autoimmune disease characterized by both inflammatory and fibrotic processes, for which effective therapies remain limited,” said Christopher Denton, PhD, FRCP, FMedSci, Professor of Experimental Rheumatology at the University College London and Consultant Rheumatologist and Head of the Centre for Rheumatology at the Royal Free Hospital, London. “Tibulizumab’s dual-targeting mechanism offers a novel strategy by concurrently targeting two pivotal pathways involved in inflammation and fibrosis. This mechanism holds the potential to address the multi-organ pathology of SSc and help improve the lives of patients with SSc.” ABOUT TibuSURE TibuSURE is a global Phase 2 double-blind, placebo-controlled study evaluating 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 and a 28-week open-label extension (OLE). The primary endpoint is the modified Rodnan Skin Score (mRSS), with key efficacy endpoints including lung disease assessed by quantitative high-resolution computed tomography (qHRCT) and forced vital capacity (FVC), physical function measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the revised Combined Response Index in Systemic Sclerosis (rCRISS). 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 currently being evaluated in a Phase 2 study in adults with systemic sclerosis and is expected to enter Phase 2 clinical development 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. Tibulizumab is an investigational compound that is not approved for marketing by the FDA or any other regulatory authority. 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. SOURCE: Zura Bio