Zura Bio begins phase 2 trial for hidradenitis suppurativa treatment

Published 20/05/2025, 11:38
Zura Bio begins phase 2 trial for hidradenitis suppurativa treatment

HENDERSON, Nev. - Zura Bio Limited (NASDAQ: ZURA), an immunology-focused biopharmaceutical company with a market capitalization of $66.82 million, has announced the launch of a global Phase 2 clinical trial named TibuSHIELD. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt, though it faces significant cash burn rates typical of clinical-stage biotech firms. The study is set to evaluate the safety and efficacy of tibulizumab, an investigational drug, in adults with moderate to severe hidradenitis suppurativa (HS), a chronic skin condition.

TibuSHIELD aims to enroll approximately 180 participants across the United States, Canada, and Europe. The trial will span 28 weeks, including a 16-week primary efficacy assessment phase followed by a 12-week safety follow-up. An optional open-label extension is also part of the study design. With a current ratio of 8.14, the company appears well-positioned to fund its clinical programs, though investors should note that InvestingPro analysis reveals rapid cash utilization. Researchers expect to release topline results for the primary efficacy endpoint at Week 16 in the third quarter of 2026.

The investigational therapy, tibulizumab, targets both B-cell activating factor (BAFF) and interleukin-17A (IL-17A) pathways, which are believed to play a role in the inflammatory process of HS. The primary endpoint of TibuSHIELD is the percent change from baseline in total abscess and nodule count at Week 16. Secondary endpoints include the proportion of participants achieving significant reductions in abscess and nodule count, among other safety and tolerability assessments.

HS is a debilitating condition characterized by painful skin lesions and has a significant impact on patients’ quality of life. Despite its prevalence, effective treatment options are limited, and many patients struggle to find relief with existing therapies.

Tibulizumab is also being evaluated in another Phase 2 clinical study for systemic sclerosis and has undergone previous Phase 1/1b studies for Sjögren’s syndrome and rheumatoid arthritis. However, the drug has not received approval from the U.S. Food and Drug Administration (FDA) or any other regulatory body, and its safety and efficacy remain to be established.

Zura Bio’s Chief Medical Officer, Kiran Nistala, emphasized the importance of the TibuSHIELD trial as a key step in advancing treatment options for patients with severe inflammatory diseases.

This news is based on a press release statement from Zura Bio Limited. The company’s ongoing research and development efforts reflect their dedication to addressing unmet needs in autoimmune and inflammatory diseases through innovative therapeutic approaches. While the stock has experienced significant volatility, with analyst price targets ranging from $3 to $26, InvestingPro subscribers can access 8 additional key insights about ZURA’s financial health and market position to make more informed investment decisions.

In other recent news, Zura Bio Ltd. reported its fourth-quarter and full-year 2024 financial results, posting a net loss of $0.15 per share, which was narrower than the anticipated $0.19 per share loss. The company ended the year with approximately $176.5 million in cash, expected to sustain operations through 2027. H.C. Wainwright adjusted its price target for Zura Bio to $3.00 from $5.00, maintaining a Neutral rating, while Chardan Capital Markets lowered its target to $10.00 from $12.00 but kept a Buy rating. Guggenheim reiterated its Buy rating with a $15.00 price target, expressing confidence in Zura Bio’s financial stability and ongoing clinical programs.

Zura Bio is actively advancing its clinical trials, particularly with its drug candidate tibulizumab, which is in Phase 2 studies for systemic sclerosis and is set to begin trials for hidradenitis suppurativa in the second quarter of 2025. Results from these trials are expected in 2026. The company is also evaluating other drug candidates, such as crebankitug and torudokimab, with strategic decisions contingent on external data. Leerink Partners maintained an Outperform rating with a $12.00 price target, noting Zura Bio’s stable pipeline and upcoming trial data as key factors for investors to watch.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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