Zura's Make-or-Break Year Ahead: Will TibuSHIELD And TibuSURE Trials Deliver Or Disappoint?

Zura Bio

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(RTTNews) - 2026 could be a pivotal year for Zura Bio Ltd. (ZURA), with key data readouts for its lead investigational drug expected to significantly influence the company's strategic direction and market position.

Zura is a clinical-stage, multi-asset immunology company advancing treatments for immune-mediated diseases where there is an unmet medical need. Its lead product candidate is Tibulizumab, a potential first-in-class dual-pathway biologic designed to target cytokines IL-17A and BAFF.

Tibulizumab is currently being evaluated in two global phase 2 studies, dubbed TibuSHIELD and TibuSURE.

-- TibuSHIELD is a global phase 2 clinical study evaluating Tibulizumab in adults with moderate to severe 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. AbbVie's Humira, Novartis' Cosentyx, and UCB's Bimzelx are some of the approved treatments for Hidradenitis suppurativa.

Initiated in May 2025, the TibuSHIELD trial is designed to enrol about 180 adults with moderate to severe HS, who 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 open-label extension. The primary endpoint of the study is the percent change from baseline in total abscess and nodule (AN) count at Week 16.

The company expects to report topline results from the TibuSHIELD trial in Q3 2026.

-- TibuSURE is a global phase 2 study evaluating Tibulizumab for the treatment of systemic sclerosis (SSc) in adults.

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. It primarily affects the skin and lungs but can also impact the heart, liver, kidneys, digestive tract, and vascular system, with common symptoms including skin thickening and extreme sensitivity to cold in the extremities.

Initiated in December 2024, the TibuSURE study is designed to enrol roughly 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).

The topline results from the TibuSURE study are expected in Q4 2026.

The company has two more investigational drugs in its pipeline - Crebankitug and Torudokimab.

Crebankitug and Torudokimab have completed phase 1/1b studies and are being evaluated for their potential across a range of autoimmune and inflammatory conditions.

Cash Position

As of June 30, 2025, Zura Bio had cash and cash equivalents of $154.5 million, expected to be sufficient to support operations until 2027.

Zura Bio Limited made its debut on the Nasdaq Capital Market on March 21, 2023, under the ticker symbol "ZURA", following a business combination with JATT Acquisition Corp, a special purpose acquisition company (NYSE: JATT).

In the last 1 year, ZURA has traded in a range of $0.97 to $5.07. The stock closed yesterday's trading at $4.17, up 6.10%.