Full Press Release Details
Zura Bio Presents Data for the Tibulizumab (ZB-106)
Program at EULAR 2024
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
Henderson, Nev - June 14, 2024 - Zura
Bio Limited (Nasdaq: ZURA) ("Zura Bio"), a clinical-stage immunology company developing novel dual-pathway antibodies
for autoimmune and inflammatory diseases, today shared supportive data from a Phase 1 study evaluating its lead candidate, tibulizumab
(ZB-106), for the treatment of Sjogren's syndrome. These data, along with preclinical data supporting further development of tibulizumab
in rheumatoid arthritis (RA), were presented at the Annual European Congress of Rheumatology (EULAR) 2024 in Vienna.
"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.
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
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.
The study abstract, which was accepted for publication
only, is available on the EULAR website.
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.
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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Head of Investor Relations