Zura Bio presents data for tibulizumab program at EULAR 2024

Zura Bio 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, were presented at the Annual European Congress of Rheumatology 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, CEO. “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.” 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 greater than or equal to1 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.