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ZURA BIO LTD (ZURA)

(10% Negative) ZURA BIO LTD (ZURA) Announces Delay in identified Development Timeline Due to Geopolitical Situation, Patient Enrollment Issues, Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

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  • News bot Aug. 17, 2026, 11:02 a.m.

    📋 ZURA BIO LTD (ZURA) - Clinical Trial Update

    Filing Date: 2026-08-17

    Accepted: 2026-08-17 07:00:44

    Event Type: Clinical Trial Update

    Event Details:

    ZURA BIO LTD (ZURA) Announces Clinical Trial Update ZURA BIO LTD (ZURA) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: identified
    • Clinical Stage: clinical trial
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Geopolitical Situation, Patient Enrollment, Regulatory Process
      • targeting mechanisms demonstrating HS efficacy signal1,2 Pooled placebo (contemporaneous cohorts) 36% Observed sHiSCR50** Responders at Week 16 by Treatment Arm1,2 Recent clinical data supports the hypothesis that B cells are key drivers of disease rather than bystanders in HS* (*) Data derived from a randomized, placebo-controlled, multi-arm hidradenitis suppurativa platform study (ClinicalTrials.gov Identifier: NCT0382
      • Targeting more than one pathway is a rational approach to address low or inadequate response rates in complex immune-mediated diseases Early clinical readouts across a range of immune-mediated indications have already demonstrated the potential of bispecific antibodies to break through efficacy ceilings5 Untapped market potential across disease areas of interest ~$5B 2026
      • targeting * sHiSCR50: modified HiSCR50 omitting the “no increase in abscess count” criterion; For all studies, HiSCR50 was the primary endpoint except LOTUS (abdakibart; HiSCR75) and the Novartis platform study (ianalumab, remibrutinib, iscalimab; sHiSCR50). Note: Data are derived from separate clinical trials with differences in design and patient populations. No head-to-head clinical trials have been conducted to date; cross-trial comparison limitations exist. Investigational drug Placebo response rate22 Orthogonal nature of IL-17 and BAFF pathways increases confidence in potential benefit over IL-17 inhibition alone Targets distinct biology of HS Tibulizumab is designed to target distinct orthogonal pathways, increasing probability of additive effect Targets IL-17, the most validated MoA in HS IL-17-binding scFv from ixekizumab (a potent IL-17 pathway inhibitor) BAFF Persistence of B cells leads to increased cytokines, T cell activation, and autoantibodies De-risked, biologically relevant approach to potentially break through efficacy ceilings in HS23 Phase 2 study ongoing in moderate-to-severe HS Efficacy Endpoints Primary Endpoint • Percent change from baseline in AN count at Week 16 Additional Endpoints* • HiSCR50 and HiSCR75 • Draining Tunnel Count • IHS4 • DLQI • Skin pain NRS • PK/PD assessments Key Inclusion Criteria • Adults with moderate-to-severe HS, defined as: – Hurley Stage II/III (up to 40% Stage III allowed) – Total abscess and inflammatory nodule (AN) count ≥5 • Up to 30% of participants may have prior TNF-α inhibitor exposure • Additional eligibility criteria per protocol Efficacy Period (16 weeks) OLE (16 weeks) Study timeline (weeks) 1:1:1 tibulizumab 150 mg placebo N = 247 participants tibulizumab 300 mg tibulizumab 150 mg 0 2 4 8 12 16 20 24 28 32 Week 32 Final OLE study visit (no SC dose) SC dosing at study visit = * Includes secondary and exploratory endpoints R24 Systemic Sclerosis (SSc)25 Systemic sclerosis is a progressive, multisystem autoimmune disease with limited therapeutic options* No therapies are approved that comprehensively address the multisystem pathology of SSc*2 300,000 people are estimated to be living with SSc across major markets (US, EU5, Japan)1 SSc-ILD is a major cause of morbidity and mortality in SSc. Two disease-modifying treatments are approved for SSc-ILD2 Lungs Skin Characterized by Chronic Inflammation and Fibrosis Across Organs Skin fibrosis contributes to functional impairment, disability, and reduced quality of life * Two therapies are approved for SSc-ILD; however, no treatment approved for SSc addresses multiple organ systems. Sources: 1. Clarivate/DRG (accessed 19-Aug-2024

    💼 Business Developments:

    • Partnership: Not available
    • Acquisition: Not available
    • Licensing: Not available
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: ZURA BIO LTD
    • Ticker Symbol: ZURA

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