Zura Bio Expands HS Trial to 225 Patients, Sets Phase 2 Readouts in Q4 2026 and 1H 2027
Zura Bio’s new CEO Sandeep Kulkarni highlighted two pivotal Phase 2 tibulizumab readouts scheduled for Q4 2026 (hidradenitis suppurativa, 225 patients) and 1H 2027 (systemic sclerosis). Tibulizumab, a bispecific IL-17A/BAFF antibody licensed from Eli Lilly in 2023, uses tabalumab and ixekizumab CDRs to enhance efficacy in autoimmune disorders.
1. CEO Appointment and Strategic Shift
Sandeep Kulkarni joined as CEO two weeks ago after co-founding Zura Bio in 2022 and serving on its board. He describes a strategic shift from execution to data company, with two key Phase 2 tibulizumab readouts expected in Q4 2026 for hidradenitis suppurativa and in the first half of 2027 for systemic sclerosis.
2. Tibulizumab Engineering and Mechanism
Tibulizumab, licensed from Eli Lilly in 2023, is a bispecific antibody combining sequences from tabalumab and ixekizumab CDRs to target IL-17A and BAFF. Lilly’s Phase 1 studies in 78 subjects demonstrated low immunogenicity and a naturally long half-life, supporting a 300 mg Q4W dosing predicted to achieve ≥98% target engagement.
3. Phase 2 Trial Designs and Timelines
The Phase 2 hidradenitis suppurativa trial has been expanded to 225 biologic-naïve patients (up to 30% TNF inhibitor failures, excluding IL-17 failures) with abscess and nodule count as the primary endpoint, powered for HiSCR 75 assuming a 20–25% placebo-adjusted delta. The systemic sclerosis program targets diffuse subtype patients (approx. two-thirds with ILD) and is slated to report data in the first half of 2027.