tibulizumab (ZB-106) / Eli Lilly, Zura Bio - LARVOL DELTA

TibuSURE (SSc): The Phase 2 clinical study evaluating tibulizumab in adults with SSc has completed and exceeded enrollment, with 91 participants. Topline data are anticipated in the first half of 2027. (Businesswire)

Enrollment closed • P2 data • Immunology • Systemic Sclerosis

NEXUS-PMR (PMR) — new indication (Businesswire) - "Zura has engaged with the U.S. Food and Drug Administration (FDA) and received feedback that was constructive and supportive of the Company's proposed development strategy. Incorporating this feedback, Zura plans to initiate a Phase 2 study, NEXUS-PMR, evaluating tibulizumab in adult participants with PMR by year end 2026."

FDA event • New P2 trial • Immunology • Rheumatology

TibuSHIELD (HS): The Phase 2 clinical study evaluating tibulizumab in adults with hidradenitis suppurativa (HS) has completed and exceeded enrollment, with 247 participants. Topline data are anticipated in the fourth quarter of 2026. (Businesswire)

Enrollment closed • P2 data • Hidradenitis Suppurativa • Immunology

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) (clinicaltrials.gov) - P2 | N=80 | Active, not recruiting | Sponsor: Zura Bio Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Scleroderma • Systemic Sclerosis

TibuSHIELD: Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense (clinicaltrials.gov) - P2 | N=225 | Active, not recruiting | Sponsor: Zura Bio Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation

Zura Bio…Expands Tibulizumab Program (Businesswire) - "...Zura plans to initiate a Phase 2 study in a third immune-mediated indication by year end 2026. Indication expansion of tibulizumab reflects Zura’s belief in the broad potential of IL-17 and BAFF dual pathway inhibition across immune-mediated diseases. Zura plans to announce the new indication prior to study initiation."

New indication • New P2 trial • Immunology

Zura Bio Exceeds Enrollment Target in Both Hidradenitis Suppurativa (HS) & Systemic Sclerosis (SSc) Phase 2 Studies… (Businesswire) - "Zura has completed enrollment of the Phase 2 TibuSHIELD trial of tibulizumab in adults with HS. The TibuSHIELD trial exceeded the target enrollment, with 247 participants enrolled. Zura remains on track to complete enrollment of the Phase 2 TibuSURE trial of tibulizumab in adults with early diffuse cutaneous SSc in early July. The TibuSURE trial has already exceeded the target enrollment of 80 participants. Exceeding enrollment targets in both TibuSHIELD and TibuSURE reflects the significant unmet need facing patients with HS and SSc. Topline data from TibuSHIELD are expected in the fourth quarter of 2026. Topline data from TibuSURE are expected in H1 2027."

Enrollment status • P2 data • Hidradenitis Suppurativa • Systemic Sclerosis

TibuSHIELD: Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense (clinicaltrials.gov) - P2 | N=225 | Recruiting | Sponsor: Zura Bio Inc

Trial initiation date • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation

Zura Bio Reports First Quarter 2026 Financial Results and Recent Corporate Updates (PharmiWeb) - "TibuSHIELD (HS): The Phase 2 clinical study evaluating tibulizumab in adult participants with HS is ongoing, with enrollment of approximately 225 patients on track. Topline data are anticipated in the fourth quarter of 2026; TibuSURE (SSc): The Phase 2 clinical study evaluating tibulizumab in adult participants with SSc is ongoing, with enrollment of approximately 80 patients on track. Topline data are anticipated in the first half of 2027...Additionally, Zura is conducting a disciplined evaluation of potential new indications for tibulizumab."

Enrollment status • P2 data • Hidradenitis Suppurativa • Systemic Sclerosis

Corporate Highlights and Anticipated Milestones - Tibulizumab (ZB‑106) (Businesswire) - "(i) Hidradenitis suppurativa (HS) - Phase 2 TibuSHIELD:...Topline data are anticipated in the fourth quarter of 2026....; (ii) Systemic sclerosis (SSc) - Phase 2 TibuSURE: The Phase 2 TibuSURE clinical study evaluating tibulizumab in adult participants with SSc is ongoing, with topline data anticipated in the first half of 2027."

P2 data • Hidradenitis Suppurativa • Systemic Sclerosis

TIBUSURE: A PHASE 2, GLOBAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH OPEN-LABEL EXTENSION TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TIBULIZUMAB IN SYSTEMIC SCLEROSIS (SSWC 2026) - P2 | "TibuSURE is the first study to evaluate dual inhibition of IL-17A and BAFF with tibulizumab in dcSSc, aiming to evaluate skin and lung outcomes."

Clinical • P2 data • Cardiovascular • Fibrosis • Immunology • Inflammation • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Sjogren's Syndrome • Systemic Sclerosis • IL17A

ZB-106-SS-201: A study to find if tibulizumab works and how safe it is in participants with systemic sclerosis (clinicaltrialsregister.eu) - P1/2 | N=37 | Recruiting | Sponsor: Zura Bio Inc.

New P1/2 trial • Immunology • Scleroderma • Systemic Sclerosis

ZB-106-HS-202: A study to determine the efficacy, safety, and tolerability of tibulizumab in adults with hidradenitis suppurativa (clinicaltrialsregister.eu) - P1/2 | N=90 | Recruiting | Sponsor: Zura Bio Inc.

New P1/2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

Zura Bio to Present Phase 2 TibuSURE Study Design Poster Evaluating Dual IL-17A and BAFF Inhibition in Systemic Sclerosis at 9th Systemic Sclerosis World Congress (Businesswire) - "The poster, titled 'TibuSURE: A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study with Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Tibulizumab in Adults with Systemic Sclerosis' (Abstract ID 184; Poster P.267), outlines the rationale and design of the global Phase 2 study....The ongoing global Phase 2 study is expected to enroll approximately 80 adults who will be randomized 1:1 to receive tibulizumab or placebo every four weeks for 24 weeks, followed by a 28-week open-label extension....Topline results are currently anticipated in the first half of 2027."

Clinical protocol • P2 data • Systemic Sclerosis

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Zura Bio Inc | Trial completion date: May 2027 ➔ Jan 2028 | Trial primary completion date: Dec 2026 ➔ May 2027

Trial completion date • Trial primary completion date • Immunology • Scleroderma • Systemic Sclerosis

Zura Bio...outlined its near-term clinical milestones and strategy at Guggenheim Securities’ Emerging Outlook Biotech Summit 2026, emphasizing upcoming Phase 2 readouts for its lead bispecific antibody, tibulizumab, in autoimmune and inflammatory diseases. (MarketBeat) - "New CEO Sandeep Kulkarni says Zura is shifting 'from being an execution company to being a data company,' with two pivotal Phase 2 readouts expected — Q4 this year (hidradenitis suppurativa) and the first half of 2027 (systemic sclerosis)....The HS Phase 2 was expanded to 225 patients with abscess and nodule (AN) count as the primary endpoint and is powered for HiSCR75 assuming a 20–25% placebo-adjusted delta; the trial focuses on biologic‑naïve patients (allows up to 30% TNF inhibitor failures and excludes prior IL‑17 failures) to improve signal detection."

P2 data • Trial status • Hidradenitis Suppurativa • Systemic Sclerosis

Anticipated Clinical Trial Readouts (Businesswire) - "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."

Enrollment status • P2 data • Hidradenitis Suppurativa • Systemic Sclerosis

PROGRAM UPDATES: Tibulizumab (Businesswire) - "(i) TibuSHIELD (HS): The Phase 2 clinical trial in adults with HS progressed as planned. Topline data are expected in the third quarter of 2026; (ii) TibuSURE (SSc): The Phase 2 clinical trial in adults with SSc continued to advance during the quarter. Topline data are expected in the fourth quarter of 2026."

P2 data • Trial status • Hidradenitis Suppurativa • Systemic Sclerosis

PIPELINE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES:…Hidradenitis suppurativa (Businesswire) - "In the second quarter of 2025, Zura Bio initiated TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe HS. A topline data readout is anticipated in the third quarter of 2026."

P2 data • Trial status • Hidradenitis Suppurativa

PIPELINE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES:…Systemic sclerosis (Businesswire) - "The Company also continued to advance TibuSURE, a global Phase 2 clinical study evaluating tibulizumab in adults with SSc. A topline data readout is anticipated in the fourth quarter of 2026."

P2 data • Trial status • Systemic Sclerosis

TibuSHIELD: Tibulizumab Skin Healing and Inflammation Evaluation for Lasting Defense (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Zura Bio Inc

New P2 trial • Dermatology • Hidradenitis Suppurativa • Immunology • Inflammation

Zura Bio Launches Global Phase 2 TibuSHIELD Study to Evaluate Tibulizumab in Adults with Hidradenitis Suppurativa (Businesswire) - "Zura Bio Limited...announced the launch of TibuSHIELD, a global Phase 2 clinical study evaluating tibulizumab in adults with moderate to severe HS....TibuSHIELD is designed to enroll approximately 180 adults with moderate to severe HS across the United States, Canada, and Europe....Topline results for the primary efficacy endpoint at Week 16 are expected in the third quarter of 2026."

New P2 trial • Hidradenitis Suppurativa

Zura Bio Reports First Quarter 2025 Financial Results and Recent Corporate Updates (Businesswire) - "In the first quarter of 2025, Zura Bio continued to advance its ongoing Phase 2 TibuSURE trial evaluating tibulizumab in adults with SSc....R&D expenses for the first quarter of 2025 were $10.5 million, compared to $3.6 million for the first quarter of 2024. The increase was primarily driven by increases of $3.7 million for contract research organization (CRO) costs and $2.1 million for manufacturing costs for our product candidates, as well as $0.6 million for cash and non-cash compensation costs for personnel in research and development functions as we advance our Phase 2 clinical trials evaluating tibulizumab in SSc and HS."

Commercial • Trial status • Hidradenitis Suppurativa • Systemic Sclerosis

Zura Bio Reports Full Year 2024 Financial Results and Recent Corporate Updates (Businesswire) - "Cash runway anticipated through 2027, supporting operations and funding anticipated tibulizumab data readouts in SSc and hidradenitis suppurativa (HS)....Hidradenitis suppurativa: Zura Bio plans to initiate a Phase 2 trial for the treatment of adults with HS in the second quarter of 2025....Research and development expenses were $24.4 million for the year ended December 31, 2024, a decrease of $19.6 million compared to $44.0 million for the year ended December 31, 2023. The decrease was primarily due to $27.2 million related to the acquisition of tibulizumab from Eli Lilly and Company ('Lilly') during the year ended December 31, 2023."

Commercial • New P2 trial • Hidradenitis Suppurativa • Systemic Sclerosis

Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE) (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Zura Bio Inc

New P2 trial • Immunology • Scleroderma • Systemic Sclerosis