tozorakimab (MEDI3506) / AstraZeneca 
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  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Trial completion date, Trial primary completion date:  MIRANDA: Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations (clinicaltrials.gov) -  Jul 30, 2024   
    P3,  N=1240, Recruiting, 
    The PK/TE model reliably quantified the relationship between PK and systemic TE of tozorakimab, with potential utility for predicting clinical dose-response relationships and supporting clinical dose selection. Trial completion date: Dec 2026 --> Aug 2026 | Trial primary completion date: Sep 2026 --> Jun 2026
  • ||||||||||  Clinical, Journal:  Towards precision medicine in COPD: Targeting type 2 cytokines and alarmins. (Pubmed Central) -  Jul 2, 2024   
    300 eosinophils/?L treated with dupilumab (anti-IL-4R?)...Several ongoing RCTs are evaluating the efficacy and safety of anti-TSLP (tezepelumab), anti-IL-33 (itepekimab, tozorakimab), and anti-ST2 (astegolimab) in patients with COPD, who experience exacerbations. In conclusion, targeting T2 inflammation or epithelial-derived alarmins might represent a step forward in precision medicine for the treatment of a subset of COPD.
  • ||||||||||  Review, Journal:  Advancements in Diabetic Kidney Disease Management: Integrating Innovative Therapies and Targeted Drug Development. (Pubmed Central) -  May 20, 2024   
    Emerging agents including GLP-1 agonists, anti-inflammatory agents like bardoxolone, and mineralocorticoid receptor antagonists show promise in mitigating DKD progression. Many novel therapies including monoclonal antibodies CSL346, Lixudebart, and tozorakimab, mesenchymal stem/stromal cell infusion, and cannabinoid-1 receptor inverse agonism via INV-202 are currently in clinical trials and present opportunities for further drug development.
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Distinct Pharmacological Profiles of IL-33 Antibodies (San Diego Convention Center, Area F (Hall A-B2, Ground Level)) -  Feb 20, 2024 - Abstract #ATS2024ATS_3239;    
    From the range of IL-33 antibodies tested, the ability to inhibit IL-33ox biological effects was unique to tozorakimab and appeared to be dependent on epitope, which is distinct for tozorakimab versus other IL-33 antibodies. Tozorakimab is under clinical investigation to reduce excess inflammation and epithelial remodelling in IL-33-driven disease.
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Trial completion:  A Phase 2b Diabetic Kidney Disease Study (clinicaltrials.gov) -  Jun 18, 2023   
    P2b,  N=609, Completed, 
    Trial completion date: May 2024 --> Mar 2025 | Trial primary completion date: May 2024 --> Mar 2025 Active, not recruiting --> Completed
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca, Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
    FRONTIER-1: PHASE 2B STUDY OF IL-33 BLOCKADE IN DIABETIC KIDNEY DISEASE (Focussed Oral Room 1) -  May 4, 2023 - Abstract #ERAEDTA2023ERA_EDTA_1035;    
    P2b
    This hypothesis is currently being tested in the FRONTIER-1 phase 2b clinical study. To identify the patients most likely to benefit from immunomodulatory treatment with tozorakimab, the study will conduct a retrospective analysis of albuminuria and inflammatory biomarkers.
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Trial completion date, Trial primary completion date:  TILIA: Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (clinicaltrials.gov) -  Mar 27, 2023   
    P3,  N=2352, Recruiting, 
    To identify the patients most likely to benefit from immunomodulatory treatment with tozorakimab, the study will conduct a retrospective analysis of albuminuria and inflammatory biomarkers. Trial completion date: Dec 2024 --> May 2024 | Trial primary completion date: Dec 2024 --> May 2024
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Biodistribution of Intravenously Administered Tozorakimab in Porcine Tissues (Walter E. Washington Convention Center, Area D, Hall C (Lower Level)) -  Mar 25, 2023 - Abstract #ATS2023ATS_8581;    
    Distribution to the kidney was 13% and for skin it was 6%. ELF concentration was 13% of serum levels, but showed significant variability.
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Associations of the IL-33 Signalling Pathway With Poor Clinical Outcomes and Lung Pathology in Patients With Respiratory Virus Infections at Risk of Acute Respiratory Failure (Walter E. Washington Convention Center, Room 102 A-B (Street Level)) -  Mar 25, 2023 - Abstract #ATS2023ATS_4203;    
    Tozorakimab driven endothelial cell transcriptomic signatures demonstrated strong associations of the IL-33-ST2 pathway with broad respiratory viral infections (including influenza, HRV, RSV) and pathological mechanisms including cell adhesion, hyper-inflammation and coagulation.Conclusions In summary, we provide a scientific rationale for targeting IL-33 in COVID-19 and other severe viral respiratory tract infections. Early intervention with tozorakimab has the potential to reduce IL-33-driven hyper-inflammation and remodelling of the lung alveolar capillary membrane and thereby improve clinical outcomes in hospitalised patients at risk of progressing to ARF.
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Trial completion date, Trial primary completion date:  TILIA: Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen (clinicaltrials.gov) -  Mar 24, 2023   
    P3,  N=2352, Recruiting, 
    Early intervention with tozorakimab has the potential to reduce IL-33-driven hyper-inflammation and remodelling of the lung alveolar capillary membrane and thereby improve clinical outcomes in hospitalised patients at risk of progressing to ARF. Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: May 2024 --> Dec 2024
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Enrollment closed:  A Phase 2b Diabetic Kidney Disease Study (clinicaltrials.gov) -  Oct 21, 2022   
    P2b,  N=609, Active, not recruiting, 
    Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Oxidised IL-33 signals via RAGE/EGFR to drive a COPD-associated phenotype (8F) -  Jun 22, 2022 - Abstract #ERS2022ERS_2880;    
    Tozorakimab (MEDI3506), a high-affinity human IgG1 monoclonal antibody, was used to inhibit IL-33 signalling...Gene set enrichment analysis showed that gene signatures defining the effects of IL-33ox were enriched in airway epithelia from patients with severe COPD. ConclusionOur data reveal a previously unknown IL-33ox–RAGE/EGFR epithelial signalling pathway, which governs key features of COPD and could be an attractive therapeutic target.
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Enrollment closed:  Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis (clinicaltrials.gov) -  Apr 25, 2022   
    P2,  N=145, Active, not recruiting, 
    Tozorakimab is under clinical investigation to reduce excess inflammation and epithelial remodelling in IL-33-driven disease. Recruiting --> Active, not recruiting
  • ||||||||||  tozorakimab (MEDI3506) / AstraZeneca
    Trial completion date, Trial primary completion date:  Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis (clinicaltrials.gov) -  Dec 6, 2021   
    P2,  N=152, Recruiting, 
    N=322 --> 144 | Trial completion date: Dec 2022 --> Jul 2023 | Trial primary completion date: Dec 2022 --> Jul 2023 Trial completion date: Mar 2022 --> Jul 2022 | Trial primary completion date: Mar 2022 --> Jul 2022
  • ||||||||||  MEDI3506 / AstraZeneca
    [VIRTUAL] IL-33 as a Novel Target for the Treatment of Diabetic Kidney Disease () -  Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_2001;    
    Conclusion Upregulation of IL-33 in diabetic kidney, generates localised chronic kidney inflammation through autocrine signalling in GECs and MCs. This data suggest that targeting IL-33 with MEDI3506 arises as a promising therapeutic intervention for DKD, currently in Ph2b trial.