Zura Bio Presents Data for the Tibulizumab (ZB-106) Program at EULAR 2024
Zura Bio presented data on tibulizumab (ZB-106) at EULAR 2024, demonstrating promising results in treating Sjogren's syndrome and rheumatoid arthritis (RA). The Phase 1 study showed tibulizumab was well-tolerated and effective in neutralizing IL-17A and BAFF, reducing B cell counts and modulating inflammatory mediators in 25 participants. Preclinical data in a RA mouse model indicated significant reductions in disease scores and inflammation when both IL-17A and BAFF were inhibited. The studies suggest tibulizumab's potential as a dual-pathway treatment for autoimmune diseases.
- Tibulizumab (ZB-106) was well-tolerated in a Phase 1 study.
- Effective in neutralizing IL-17A and BAFF in patients with Sjogren's syndrome.
- Preclinical data supports further exploration in rheumatoid arthritis (RA).
- Study showed reduction in total B cell counts, indicating target engagement.
- Modulated inflammatory mediators, suggesting broader treatment potential.
- Preclinical RA model showed significant reduction in disease scores and inflammation.
- No specific negative aspects reported in the PR.
Insights
The recent results from Zura Bio's Phase 1 study on tibulizumab (ZB-106) offer a promising outlook for the treatment of Sjogren’s syndrome and potentially other autoimmune diseases. The study demonstrated that tibulizumab was well tolerated and achieved robust target engagement, which is a important first step in any clinical development. By neutralizing both IL-17A and BAFF, tibulizumab addresses two key pathways known to play significant roles in autoimmune responses. This dual inhibition could potentially offer more comprehensive disease control compared to single-pathway inhibitors currently in use. Additionally, the reduction in total B cell counts and inflammatory mediators suggests that tibulizumab not only engages its targets effectively but also has a broad immunomodulatory effect.
From a medical research perspective, these findings warrant further exploration in larger, more diverse populations. The potential to repurpose tibulizumab for other conditions, like rheumatoid arthritis (RA), as suggested by the preclinical data, could expand its market significantly. However, it is essential to validate these early-phase results with rigorous, peer-reviewed studies to establish its efficacy and safety comprehensively.
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From a market perspective, Zura Bio’s tibulizumab data could have significant implications. The data indicates a potential breakthrough in autoimmune and inflammatory disease treatment, which could position Zura Bio as a strong competitor in this market. The dual inhibition of IL-17A and BAFF is particularly noteworthy because it provides a new therapeutic approach compared to existing treatments that generally target a single pathway. This could translate to better patient outcomes and a competitive edge for Zura Bio.
Moreover, Sjogren’s syndrome and rheumatoid arthritis are substantial markets with high unmet needs. If tibulizumab proves effective in further clinical trials, Zura Bio could capture a significant share of these markets. However, investors should be mindful of the inherent risks in drug development, including potential setbacks in later-stage trials and the need for substantial financing to support ongoing research and commercialization efforts. The company's ability to navigate these challenges will be important for its long-term success.
Rating: 1
Tibulizumab (ZB-106) was well tolerated and neutralized IL-17A and BAFF in a Phase 1 study in patients with Sjogren’s syndrome
Preclinical data demonstrating the potential of dual inhibition of IL-17A and BAFF in a rheumatoid arthritis animal model support clinical development
“Collectively, these data add to early-phase evidence demonstrating that dual-inhibition of both IL-17A and BAFF could be a breakthrough approach for autoimmune and inflammatory diseases in which single-pathway inhibition is the standard of care,” stated Robert Lisicki, Chief Executive Officer. “The results in Sjogren’s syndrome demonstrate that tibulizumab achieved robust target engagement, nearing maximum serum levels following single, well-tolerated subcutaneous doses at four-week intervals. Further, the preclinical results suggest dual-pathway inhibition may warrant clinical exploration in RA and other autoimmune diseases, adding to the breadth of potential we see with tibulizumab.”
Key Findings from Phase 1 Study of Tibulizumab in Sjogren’s Syndrome
The randomized, double-blind, placebo-controlled Phase 1 study evaluated four ascending doses of tibulizumab in 25 participants with Sjogren’s syndrome. Twenty-one participants in the 12-week study received ≥1 dose of tibulizumab (30mg Q4W, 100mg Q4W, 300mg Q4W, 300mg Q2W), with four receiving placebo.
- Treatment with tibulizumab was generally well tolerated in patients with Sjogren’s syndrome.
- Serum levels of total IL-17A and BAFF increased following tibulizumab administration, reflecting target engagement. At doses of 100 mg Q4W and higher, the total IL-17A and BAFF concentrations appeared to plateau, suggesting the targets were engaged nearly to maximum levels.
- Throughout the study, total B cell counts were dose-dependently reduced in all participants, while administration of tibulizumab was associated with lower levels of Th1 cells. Tibulizumab was also shown to modulate inflammatory mediators, including serum amyloid A, interleukins 5 and 10, as well as basic fibroblast growth factor. These reductions suggest tibulizumab has treatment potential for additional autoimmune conditions.
The poster is available in the News and Events section on the Zura Bio website and will be archived for at least 30 days following presentation.
Key Findings from Preclinical Study of Tibulizumab in an RA Model
The preclinical study was designed to evaluate the respective and combined benefits of inhibiting IL-17A and BAFF in a mouse model of RA. Mice received IL-17A antibodies and/or BAFF antibodies, or a control antibody.
- Cumulative clinical disease scores were significantly reduced in mice treated with the combination of anti-IL-17A and anti-BAFF compared to the isotype control (p<0.001); combined IL-17A and BAFF inhibition also resulted in less signs of disease compared to individually targeted treatment.
- Combined IL-17A and BAFF inhibition reduced inflammation significantly compared to the control (p<0.05).
- Combined IL-17A and BAFF inhibition was associated with a significant reduction of anti-collagen antibodies compared to the control (p<0.01).
The study abstract, which was accepted for publication only, is available on the EULAR website.
ABOUT TIBULIZUMAB
Tibulizumab, a humanized bispecific dual antagonist antibody, is a fusion of TALTZ® (ixekizumab) and tabalumab that has been engineered to bind to and neutralize both IL-17A and BAFF. Tibulizumab is expected to enter Phase 2 clinical development for the treatment of systemic sclerosis in Q4-2024 and hidradenitis suppurativa in Q2-2025. Completed tibulizumab studies include Phase 1/1b trials in Sjogren’s syndrome and rheumatoid arthritis.
ABOUT ZURA BIO
Zura Bio is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases. Currently, Zura Bio is developing three assets which have completed Phase 1/1b studies and are Phase 2 ready. The company is developing a portfolio of therapeutic indications for tibulizumab (ZB-106), ZB-168, and torudokimab (ZB-880), with a goal of demonstrating their efficacy, safety, and dosing convenience in autoimmune and inflammatory diseases, including systemic sclerosis and other novel indications with unmet needs.
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Megan K. Weinshank
Head of Investor Relations
ir@zurabio.com
Source: Zura Bio Limited
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