torudokimab (ZB-880) / Eli Lilly, Zura Bio - LARVOL DELTA

Tozorakimab restores epithelial dysfunction in COPD (ERS 2026) - "Tozorakimab is a human therapeutic mAb with a dual pharmacological profile that can inhibit both IL-33 activities with demonstrated ability to reverse epithelial dysfunction in COPD. Tozorakimab is under clinical investigation in COPD. Table."

Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases • EGFR • IL33 • IL5 • MUC5AC

Additional Clinical Stage Product Candidates (Businesswire) - "...Zura is continuing its evaluation of potential development approaches for torudokimab (ZB‑880) and crebankitug (ZB‑168), informed by current clinical and translational evidence and ongoing assessment of the evolving competitive landscape."

Clinical • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Ulcerative Colitis

Integrated multi-omics approaches reveal IL-33 as a central pathogenic factor and potential therapeutic target in autoimmune hepatitis (EASL 2026) - "Additionally, the therapeutic efficacy of an anti-IL-33 monoclonal antibody (Torudokimab) was assessed in an S100-induced AIH murine model by measuring liver injury biomarkers and immunoglobulin levels... This study establishes the causal role of IL-33 in the pathogenesis of AIH and identifies a specific subset of NRG3+ LSECs as its primary source. Importantly, in vivo data show that targeting IL-33 effectively reverses liver injury and attenuates excessive immunoglobulin production, highlighting its potential as a novel therapeutic strategy for AIH treatment."

Autoimmune Hepatitis • Hepatology • Immunology • Inflammation • Liver Failure • IL33 • NRG3

PIPELINE HIGHLIGHTS AND UPCOMING ANTICIPATED MILESTONES (Businesswire) - "Torudokimab:...The Company continues to monitor external clinical data from ongoing IL-33/ST2-targeted programs in asthma and chronic obstructive pulmonary disease, including Phase 2b and Phase 3 trials. An additional IL-33/ST2 data readout is expected in 2026."

Clinical data • Asthma • Chronic Obstructive Pulmonary Disease

Zura Bio Reports Full Year 2023 Financial Results, Business Highlights, and Appoints Robert Lisicki as Chief Executive Officer (Businesswire) - "Concurrently, we're advancing...torudokimab towards Phase 2 readiness while closely monitoring external readouts expected in 2024....Additionally, the Company is monitoring Phase 2 and Phase 3 external catalysts in asthma and chronic obstructive pulmonary disease."

P2 data • Asthma • Chronic Obstructive Pulmonary Disease

Zura Bio Announces Two Immunology Abstracts Presented at the World Allergy Congress in Bangkok (Businesswire) - "Zura Bio Limited....today announced two abstracts were accepted and presented at World Allergy Congress (WAC), held December 1 – 3, 2023 in Bangkok, Thailand. The abstracts highlight Zura Bio’s informative research for ZB-168, an anti-IL-7Rα monoclonal antibody with potential across a broad set of indications where the IL-7 or TSLP pathways may be involved, and ZB-880 (torudokimab), a fully human, high affinity monoclonal antibody that neutralizes IL-33 and also has potential for a broad range of indications."

Biomarker • Clinical data • Atopic Dermatitis • Immunology

Zura Bio Reports Second Quarter 2023 Financial Results and Recent Business Highlights (Businesswire) - "ZB-880 (torudokimab): Prepare to initiate Phase 2 trial of ZB-880, an anti-IL-33 antibody, for the treatment of asthma in 2024. Pending Phase 2 and Phase 3 external catalysts in asthma and chronic obstructive pulmonary disease."

New P2 trial • Asthma • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Generation and Characterization of Torudokimab (LY3375880): A Monoclonal Antibody That Neutralizes Interleukin-33. (PubMed, J Inflamm Res) - "Torudokimab's half-life in cynomolgous monkey projects monthly dosing in the clinic. Due to torudokimab's high affinity, its ability to completely neutralize IL-33 activity in vitro and in vivo, and the observed cynomolgus monkey pharmacokinetic properties, this molecule was selected for clinical development."

Journal • Allergy • IL13 • IL33 • IL4 • IL5

ADmIRe: A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=136; Terminated; Sponsor: Eli Lilly and Company; N=200 ➔ 136; Active, not recruiting ➔ Terminated; The study was terminated for lack of efficacy after an interim analysis was performed

Clinical • Enrollment change • Trial termination

ADmIRe: A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=200; Active, not recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Feb 2021 ➔ Feb 2020

Trial completion date

ADmIRe: A Study of LY3375880 in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=200; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study of Different Injectable Formulations of LY3375880 in Healthy Participants (clinicaltrials.gov) - P1; N=83; Completed; Sponsor: Eli Lilly and Company; Active, not recruiting ➔ Completed

Clinical • Trial completion

A Study of Different Injectable Formulations of LY3375880 in Healthy Participants (clinicaltrials.gov) - P1; N=74; Active, not recruiting; Sponsor: Eli Lilly and Company; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study of Different Injectable Formulations of LY3375880 in Healthy Participants (clinicaltrials.gov) - P1; N=74; Recruiting; Sponsor: Eli Lilly and Company; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open