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

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

Zura Bio Launches Global Phase 2 TibuSURE Study to Evaluate Tibulizumab in Adults With Systemic Sclerosis (Businesswire) - "Zura Bio Limited...today announced the launch of TibuSURE, a Phase 2 global study evaluating tibulizumab for the treatment of systemic sclerosis (SSc) in adults."

New P2 trial • Immunology • Systemic Sclerosis

Zura Bio Reports Third Quarter 2024 Financial Results and Recent Corporate Updates (Businesswire) - "The Orphan Drug Designation application was completed, and the request was submitted to the U.S. Food and Drug Administration (FDA) in Q4 2024. The Phase 2 clinical trial of tibulizumab for the treatment of SSc is anticipated to initiate in Q4 2024."

New P2 trial • Orphan drug • Immunology • Scleroderma • Systemic Sclerosis

Zura Bio Announces Submission of Protocol to U.S. Food and Drug Administration for the Phase 2 Study of Tibulizumab in Adults with Systemic Sclerosis (Businesswire) - "Zura Bio Limited...announced the submission of a protocol to its open Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a Phase 2 study evaluating tibulizumab, a humanized tetravalent bispecific dual antagonist antibody designed to neutralize both IL-17A and BAFF, for the treatment of systemic sclerosis (SSc) in adults....The trial is expected to initiate in Q4 2024, with an Orphan Drug Designation request already submitted to the FDA in the same quarter."

IND • New P2 trial • Orphan drug • Immunology • Systemic Sclerosis

Zura Bio Reports Second Quarter 2024 Financial Results and Recent Business Highlights (Businesswire) - "Expect to initiate Phase 2 studies evaluating tibulizumab for the treatment of systemic sclerosis (SSc) in 4Q 2024 and hidradenitis suppurativa (HS) in 2Q 2025...Research and Development (R&D) expenses: R&D expenses were $5.5 million for the second quarter of 2024, a decrease of $22.7 million compared to $28.2 million for the same period in 2023. The decrease was primarily due to $27.2 million related to the acquisition of tibulizumab from Eli Lilly and Company ('Lilly') during the three months ended June 30, 2023."

Commercial • New P2 trial • Hidradenitis Suppurativa • Immunology • Scleroderma • Systemic Sclerosis

PHASE 1 CLINICAL TRIAL EVALUATING THE PHARMACOKINETICS AND PHARMACODYNAMICS OF A NOVEL IL-17A AND BAFF DUAL ANTAGONIST IN SJOGREN'S SYNDROME (EULAR 2024) - "Overall, this clinical trial demonstrated that tibulizumab was well-tolerated and that the combined neutralization of IL-17A and BAFF disrupts two key pathways involved in disease pathogenesis. These results suggest that tibulizumab may provide significant benefit to those with IL-17A and B cell-mediated autoimmune diseases, including SS, and warrants further exploration in larger clinical trials."

Clinical • P1 data • PK/PD data • Immunology • Inflammation • Sjogren's Syndrome • CXCL1 • IL17A

Zura Bio Presents Data for the Tibulizumab (ZB-106) Program at EULAR 2024 (Businesswire) - "The preclinical study was designed to evaluate the respective and combined benefits of inhibiting IL-17A and BAFF in a mouse model of RA. Mice received IL-17A antibodies and/or BAFF antibodies, or a control antibody. Cumulative clinical disease scores were significantly reduced in mice treated with the combination of anti-IL-17A and anti-BAFF compared to the isotype control (p<0.001); combined IL-17A and BAFF inhibition also resulted in less signs of disease compared to individually targeted treatment. Combined IL-17A and BAFF inhibition reduced inflammation significantly compared to the control (p<0.05). Combined IL-17A and BAFF inhibition was associated with a significant reduction of anti-collagen antibodies compared to the control (p<0.01)."

Preclinical • Rheumatoid Arthritis

Zura Bio to Present Data Exploring the Expanded Potential of Tibulizumab (ZB-106) into Sjogren's Syndrome and Rheumatoid Arthritis at EULAR 2024 (Businesswire) - "Novel, dual-pathway antibody targeting IL-17A and BAFF is expected to enter Phase 2 development in systemic sclerosis in Q4 2024 and hidradenitis suppurativa in Q2 2025."

New P2 trial • Hidradenitis Suppurativa • Immunology • Systemic Sclerosis

Zura Bio to Present Data Exploring the Expanded Potential of Tibulizumab (ZB-106) into Sjogren’s Syndrome and Rheumatoid Arthritis at EULAR 2024 (Businesswire) - "Zura Bio Limited...today announced it will present data from its tibulizumab (ZB-106) program exploring the clinical potential of the dual-pathway antibody in Sjogren's syndrome and rheumatoid arthritis (RA) at EULAR 2024, June 12-15 in Vienna....'We are excited to present translational data from our tibulizumab (ZB-106) program to help elucidate the potential to inhibit both IL-17A and BAFF in a single antibody therapy,'..."

P1 data • Rheumatoid Arthritis • Sjogren's Syndrome

Zura Bio Reports First Quarter 2024 Financial Results and Recent Business Highlights (Businesswire) - "Zura Bio Limited...today reported its first quarter 2024 financial results, and recent business highlights...Cash and cash equivalents were $89.8 million as of March 31, 2024, as compared to $99.8 million as of December 31, 2023...Tibulizumab (ZB-106): On track to commence a Phase 2 clinical trial in SSc in the fourth quarter of 2024, followed by a Phase 2 clinical trial in HS in the second quarter of 2025."

Commercial • New P2 trial • Hidradenitis Suppurativa • Systemic Sclerosis

Zura Bio Announces Oversubscribed $112.5 Million Private Placement (Businesswire) - "Zura Bio Limited...announced that it has entered into subscription agreements for a private placement that is expected to result in gross proceeds of approximately $112.5 million, before deducting placement agent fees and offering expenses (the 'Private Placement')....Anticipated proceeds from the private placement are expected to support the accelerated development of tibulizumab (ZB-106), including the planned Phase 2 clinical trial in systemic sclerosis (SSc), the initiation of a Phase 2 trial evaluating tibulizumab for the treatment of hidradenitis suppurativa (HS), and general corporate purposes."

Financing • Hidradenitis Suppurativa • Immunology • Scleroderma • Systemic Sclerosis

Zura Bio Reports Full Year 2023 Financial Results, Business Highlights, and Appoints Robert Lisicki as Chief Executive Officer (Businesswire) - "Tibulizumab (ZB-106): Zura Bio plans to initiate a Phase 2 trial of tibulizumab for the treatment of systemic sclerosis in 2H 2024. Tibulizumab is a tetravalent dual-antagonist antibody engineered by the fusion of TALTZ (ixekizumab) and tabalumab that neutralizes IL-17A and BAFF."

P2 data • Immunology • Systemic Sclerosis

Zura Bio Reports Third Quarter 2023 Financial Results and Recent Business Highlights (PharmiWeb) - "ZB-106 (tibulizumab): Initiate Phase 2 trials of ZB-106, an anti-IL-17 and anti-BAFF dual antagonist, for the treatment of systemic sclerosis and hidradenitis suppurativa in 2H-2024."

New P2 trial • Immunology • Systemic Sclerosis

Zura Bio Reports Second Quarter 2023 Financial Results and Recent Business Highlights (Businesswire) - "Research and Development (R&D) expenses: R&D expenses were $28.2 million for the second quarter ended June 30, 2023, compared to $0.1 million for the second quarter ended June 30, 2022. The increase was primarily due to expenses related to the acquisition of ZB-106 from Eli Lilly and Company....ZB-106 (tibulizumab): Initiate Phase 2 trials of ZB-106, an anti-IL-17 and anti-BAFF dual antagonist, for the treatment of systemic sclerosis and hidradenitis suppurativa in 2H-2024. ZB-168: Initiate Phase 2 trial of ZB-168, an anti-IL-7Rα inhibitor, in 2024. Pending Phase 2 external catalysts in ulcerative colitis, atopic dermatitis and additional TSLP driven catalysts."

Commercial • New P2 trial • Immunology • Inflammatory Bowel Disease • Systemic Sclerosis • Ulcerative Colitis

Zura Bio Completes Approximately $80 Million Financing with the Focus on Advancing ZB-106, a Potential First-in-class Anti-IL-17 and Anti-BAFF Dual Antagonist (Businesswire) - "Zura Bio Limited...announced the final closing of a private placement resulting in gross proceeds to Zura Bio of approximately $80 million. This funding will allow Zura Bio to initiate a Phase 2 clinical trial for ZB-106 in systemic sclerosis (SSc), followed by a Phase 2 clinical trial in hidradenitis suppurativa (HS)."

Financing • Immunology • Inflammation • Systemic Sclerosis

BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: Matthew C. Baker | N=12 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Immunology • Sjogren's Syndrome • MRI

BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's Syndrome (clinicaltrials.gov) - P2/3; N=12; Not yet recruiting; Sponsor: Matthew C. Baker; Initiation date: Nov 2020 ➔ Apr 2021

Clinical • Trial initiation date • Complement-mediated Rare Disorders • Immunology • Sjogren's Syndrome • MRI

A Comprehensive Review of Biological Agents for Lupus: Beyond Single Target. (PubMed, Front Immunol) - "In addition to the various monoclonal antibodies that have been studied for a long time, such as belimumab and rituximab, we focused on another treatment for SLE, bispecific antibodies (BsAbs) such as tibulizumab, which simultaneously targets multiple pathogenic cytokines or pathways. Although the application of BsAbs in cancer has been intensively studied, their application in autoimmune diseases is still in the infant stage. This unique combined mechanism of action may provide a novel therapeutic strategy for SLE."

Journal • Review • Immunology • Inflammatory Arthritis • Lupus • Oncology • Systemic Lupus Erythematosus