HENDERSON, Nev. - Zura Bio Limited (Nasdaq: ZURA), a clinical-stage immunology company with a market capitalization of $149 million, today announced the initiation of its Phase 2 TibuSURE trial, a global study to evaluate tibulizumab in adults with systemic sclerosis (SSc). According to InvestingPro analysis, the company maintains a strong financial position with cash reserves exceeding its debt obligations. This trial is notable for investigating the combined inhibition of two key pathways, anti-BAFF and IL-17, a novel approach in the treatment of this rare autoimmune disease.
Systemic sclerosis is a complex condition characterized by inflammation and fibrosis, affecting the skin, lungs, and other organs. With limited treatment options available, the disease presents a significant unmet medical need. TibuSURE aims to address this gap by evaluating the efficacy of tibulizumab, a dual-antagonist antibody designed to target both IL-17A and BAFF. The study will involve approximately 80 participants with early diffuse cutaneous systemic sclerosis and will include a 24-week efficacy period followed by a 28-week open-label extension.
The primary endpoint of the trial is the modified Rodnan Skin Score, a measure of skin thickening, with other key endpoints including assessments of lung disease, physical function, and a combined response index specific to systemic sclerosis.
Tibulizumab has previously undergone Phase 1/1b studies for Sjögren’s syndrome and rheumatoid arthritis. Zura Bio is also planning to begin a Phase 2 clinical trial for the treatment of hidradenitis suppurativa with tibulizumab in the second quarter of 2025.
The initiation of the TibuSURE study marks a significant milestone for Zura Bio, as it continues to develop its portfolio of therapies aimed at autoimmune and inflammatory diseases. The company's development program includes three assets that have completed Phase 1/1b studies, with a focus on demonstrating efficacy, safety, and dosing convenience across various indications. InvestingPro data reveals the company maintains a healthy current ratio of 10.36, indicating strong short-term financial stability. Subscribers to InvestingPro can access 6 additional key insights about ZURA's financial health and market position.
This announcement contains forward-looking statements regarding the potential benefits of tibulizumab and Zura Bio’s development strategies. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially.
The information in this article is based on a press release statement from Zura Bio Limited.
In other recent news, Zura Bio Limited has submitted a Phase 2 study protocol to the FDA for tibulizumab, a novel therapy for treating systemic sclerosis. The trial is expected to commence in late 2024. The company also plans to initiate a Phase 2 clinical trial for tibulizumab in the treatment of hidradenitis suppurativa in 2025. Zura Bio's robust first-quarter results for 2024 ended with a cash balance of $89.8 million, following a successful funding round that raised approximately $112 million. Guggenheim maintained a Buy rating on the company, while Leerink Partners initiated coverage with an Outperform rating and Piper Sandler reiterated an Overweight rating. The company also announced the departure of its Chief Scientific Officer, Michael Howell, stating the separation was not due to any disputes. At the company's Annual General Meeting, all nine director nominees were re-elected to the board and WithumSmith+Brown, PC was ratified as the independent registered public accounting firm.
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