HENDERSON, NV, USA I May 20, 2025 I
Zura Bio Limited
(Nasdaq: ZURA) (“Zura Bio” or the “Company”), a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for a range of autoimmune and inflammatory diseases with unmet needs, today announced the launch of TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe HS.
“Hidradenitis suppurativa remains a difficult condition to manage, with many patients experiencing persistent disease activity despite currently available treatments,” said Alexa B. Kimball, MD, MPH, Professor of Dermatology at Harvard Medical School, and President and CEO of Harvard Medical Faculty Physicians at Beth Israel Deaconess Medical Center. “Studying tibulizumab represents an important opportunity to evaluate an investigational therapy designed to target multiple aspects of the inflammatory process in HS. We look forward to investigating this approach for individuals living with this challenging disease.”
TibuSHIELD is designed to enroll approximately 180 adults with moderate to severe HS across the United States, Canada, and Europe. The study will evaluate tibulizumab over a 28-week period, comprising a 16-week primary efficacy assessment and a 12-week safety follow-up, with an optional OLE. Topline results for the primary efficacy endpoint at Week 16 are expected in the third quarter of 2026.
“The initiation of TibuSHIELD marks a key milestone in our mission to advance potentially differentiated therapies for patients with severe inflammatory diseases, ” said Kiran Nistala, MBBS, PhD, Chief Medical Officer and Head of Development at Zura Bio. “Tibulizumab’s dual mechanism of action, targeting both BAFF and IL-17A, offers a novel approach for the potential treatment of hidradenitis suppurativa. We remain committed to advancing clinical development with investigators, clinical sites, and the HS community.”
The launch of this HS study follows the December 2024 initiation of TibuSURE, a global Phase 2 study evaluating tibulizumab in adults with systemic sclerosis. Tibulizumab remains an investigational product and has not been approved by any regulatory authority. Its safety and efficacy have not yet been established.
ABOUT TibuSHIELD
TibuSHIELD is a global, Phase 2, randomized, double-blind, placebo-controlled clinical study evaluating the safety, tolerability, and efficacy of tibulizumab in approximately 180 adults with moderate to severe HS. Participants are randomized 1:1:1 to receive two different doses of tibulizumab or placebo. The study includes a 16-week efficacy assessment period followed by a 12-week safety follow-up and an optional OLE.
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.
ABOUT HIDRADENITIS SUPPURATIVA
Hidradenitis suppurativa (HS), also known as acne inversa, is a chronic, progressive, and debilitating inflammatory skin disease affecting approximately 1% of the global population. HS primarily involves follicular occlusion, rupture, and secondary inflammation of hair follicles, leading to painful nodules, abscesses, sinus tracts (also referred to as draining tunnels), and scarring. Lesions typically occur in areas where skin rubs together, such as the armpits, groin, and under the breasts.
HS is associated with several comorbidities, including inflammatory arthropathies, metabolic syndrome, increased cardiovascular risk, inflammatory disorders, lymphedema, squamous cell carcinoma, and depression. The chronic pain, visible scarring, and disease burden contribute significantly to physical disability, stigmatization, unemployment, and reduced quality of life.
Currently, there is no cure for HS. Despite its relatively high prevalence and disease burden, treatment options remain limited, and many patients fail to achieve adequate disease control.
ABOUT TIBULIZUMAB
Tibulizumab is an investigational, humanized, tetravalent dual-antagonist antibody engineered by fusing Taltz® (ixekizumab) and tabalumab to bind to and neutralize both IL-17A and BAFF. It is currently being evaluated in two Phase 2 clinical studies in adults with systemic sclerosis and hidradenitis suppurativa. Prior to in-licensing, Phase 1/1b studies were conducted in patients with Sjögren’s syndrome and rheumatoid arthritis.
Tibulizumab is an investigational compound and has not been approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory authority.
ABOUT ZURA BIO
Zura Bio is a clinical-stage, multi-asset immunology company dedicated to developing novel dual-pathway antibodies for a range of autoimmune and inflammatory diseases with unmet needs. The Company’s pipeline includes dual-pathway product candidates designed to target key mechanisms of immune system imbalance, with the goal of improving efficacy, safety, and dosing convenience for patients.
Zura Bio’s lead product candidate, tibulizumab (ZB-106), is currently being evaluated in two separate Phase 2 clinical studies in adults, including TibuSURE for systemic sclerosis and TibuSHIELD for hidradenitis suppurativa. Additional product candidates, crebankitug (ZB-168) and torudokimab (ZB-880), have completed Phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions.
For more information, please visit
www.zurabio.com
.
SOURCE:
Zura Bio