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Zura Bio Targets Key 2026–2027 Trial Readouts as Lead Autoimmune Drug Advances, Eyes Transformational Data in 2026 as Tibulizumab Studies Progress

Benzinga Newsdesk 10 months ago

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Zura Bio Limited (NASDAQ:ZURA) ("Zura"), a clinical-stage biotechnology company developing novel and differentiated medicines to meaningfully improve the lives of patients with serious and debilitating autoimmune and

Zura Bio Limited (NASDAQ:ZURA) ("Zura"), a clinical-stage biotechnology company developing novel and differentiated medicines to meaningfully improve the lives of patients with serious and debilitating autoimmune and inflammatory diseases, today reported business updates and updated its outlook for 2026.

"We are excited to enter 2026, as we get closer to two potentially transformative readouts over the next 18 months for tibulizumab, starting with anticipated data from our TibuSHIELD study in patients with hidradenitis suppurativa in the fourth quarter of this year," said Kim Davis, interim Chief Executive Officer and Chief Operating Officer at Zura. "We believe tibulizumab could be a paradigm shift in addressing the unmet needs of patients suffering from complex and debilitating immune disorders."

Tibulizumab is the first and currently only in-class bispecific antibody designed to target the IL-17 and BAFF pathways. Both pathways are known to be involved in the pathogenesis of HS and SSc, with both pathways having already achieved clinical validation in HS. Zura believes this unique molecule and dual-pathway approach could address complex autoimmune diseases where multiple pathways are activated and involved in disease pathogenesis.

"Tibulizumab is among the most advanced bispecific antibodies in development for autoimmune diseases and has the potential to break through the efficacy seen with single pathway inhibitors," said Kiran Nistala, Chief Medical Officer. "We have strengthened our clinical programs in order to generate high-quality, robust data that we believe will maximize our ability to showcase the clinical benefits of this unique molecule."

Anticipated Clinical Trial Readouts

For HS, the Phase 2 TibuSHIELD study continues to enroll well, with actual enrollment tracking ahead of initial projections. Given the faster-than-expected enrollment and to improve the study's power, Zura is expanding enrollment in the TibuSHIELD study to 225 participants (up from 180 participants previously). Zura is now anticipating topline data for TibuSHIELD in the fourth quarter of 2026.

For SSc, enrollment is ongoing in the Phase 2 TibuSURE study. Based on the initial rate of enrollment observed in the study, Zura now expects to report topline data in the first half of 2027.

Cash Guidance

Zura begins 2026 with cash and cash equivalents anticipated to be sufficient to support planned corporate and clinical operations through 2027, beyond the anticipated data readouts in both HS and SSc.

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