Immunology company Zura Bio Limited (Nasdaq: ZURA) announced on Monday that it has initiated TibuSURE, a Phase 2 global study to evaluate tibulizumab for systemic sclerosis (SSc) in adults. The trial is the first to explore dual inhibition of BAFF and IL-17 pathways in this rare autoimmune disease.

TibuSURE will assess the safety, tolerability and efficacy of tibulizumab in approximately 80 participants with early diffuse cutaneous systemic sclerosis over a 24-week period, followed by a 28-week open-label extension. Key endpoints include the modified Rodnan Skin Score, lung function measures and patient-reported outcomes.

Systemic sclerosis affects 300,000 individuals globally and has limited treatment options. Tibulizumab, a bispecific antibody targeting IL-17A and BAFF, aims to address the disease's multisystem impact.

Zura Bio is also advancing tibulizumab for hidradenitis suppurativa, with Phase 2 trials planned for 2025. The company's portfolio includes additional assets, crebankitug and torudokimab, targeting autoimmune and inflammatory conditions with high unmet needs.