Zura Bio Starts Global Phase 2 Study on Tibulizumab for Hidradenitis Suppurativa

HENDERSON, NV, USA I May 20, 2025 I Zura Bio Limited (Nasdaq: ZURA), an immunology-focused company currently in the clinical stages, has announced the commencement of a global Phase 2 clinical trial named TibuSHIELD. This trial aims to examine the effects of tibulizumab in adult patients suffering from moderate to severe hidradenitis suppurativa (HS), a challenging autoimmune condition characterized by painful nodules, abscesses, and significant skin inflammation.

Hidradenitis suppurativa, often referred to as acne inversa, is a chronic skin disease that affects approximately one percent of the global population. It is marked by follicular occlusion and inflammation, primarily appearing in areas where skin tends to rub together, such as the armpits, groin, and under the breasts. The condition is associated with several other health challenges, including inflammatory arthropathies, metabolic syndrome, and an increased risk of cardiovascular issues and depression. These correlations contribute to the physical and psychological burden on patients, often resulting in stigmatization and reduced life quality.

Alexa B. Kimball, MD, MPH, a Professor of Dermatology at Harvard Medical School, remarked that hidradenitis suppurativa remains difficult to manage with existing treatment options. Many individuals continue to experience persistent symptoms despite the availability of current therapies. Tibulizumab is an investigational therapy designed to target multiple aspects of the inflammatory process in HS, presenting an important opportunity to improve treatment outcomes for those dealing with this debilitating disease.

The TibuSHIELD trial intends to enroll around 180 participants from the US, Canada, and Europe. Over a 28-week period, the trial will assess tibulizumab's efficacy and safety, with a 16-week primary efficacy evaluation followed by a 12-week safety follow-up phase. An optional open-label extension (OLE) is also available. The study aims to generate topline results regarding the primary efficacy endpoint by the third quarter of 2026.

Kiran Nistala, MBBS, PhD, Chief Medical Officer and Head of Development at Zura Bio, emphasized the significance of the TibuSHIELD trial in furthering the company's mission to develop unique therapies for severe inflammatory diseases. Tibulizumab works through a dual mechanism, targeting both BAFF and IL-17A, which offers a novel approach to potentially treating hidradenitis suppurativa.

This new study follows the earlier initiation of TibuSURE in December 2024, another global Phase 2 trial assessing tibulizumab's potential in adults with systemic sclerosis. Despite promising developments, tibulizumab remains an investigational product and is yet to receive approval from any regulatory authorities, leaving its safety and efficacy still to be confirmed.

TibuSHIELD is set up as a randomized, double-blind, placebo-controlled study. Participants are assigned one of two doses of tibulizumab or placebo in a 1:1:1 ratio. The study's primary endpoint is the percentage change from baseline in total abscess and nodule count at Week 16. Secondary endpoints include achieving at least a 50% or 75% reduction in abscesses and nodules without new abscess formation or draining fistulas. Adverse events and tolerability are key components of the safety assessments.

Zura Bio is dedicated to advancing its pipeline of therapies targeting autoimmune and inflammatory diseases with unmet medical needs. Tibulizumab, the company's leading candidate, is undergoing evaluation in two separate Phase 2 trials for systemic sclerosis and hidradenitis suppurativa. The company continues to explore additional candidates, aiming to enhance treatment efficacy, safety, and patient convenience.