lixudebart (ALE.F02) / Alentis Therap 
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  • ||||||||||  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.
  • ||||||||||  lixudebart (ALE.F02) / Alentis Therap
    Enrollment change:  Rescue of Nephrons With ALE.F02 (RENAL-F02) (clinicaltrials.gov) -  May 10, 2024   
    P2,  N=80, Recruiting, 
    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. N=60 --> 80
  • ||||||||||  lixudebart (ALE.F02) / Alentis Therap
    Expression of Exposed CLDN1 Is Linked to Early Pathological Lesions in Idiopathic Pulmonary Fibrosis (San Diego Convention Center, Area E (Hall A-B2, Ground Level)) -  Mar 17, 2024 - Abstract #ATS2024ATS_9063;    
    Exposed CLDN1 is present in areas of active matrix deposition, even in mild disease areas, suggesting a direct involvement of exposed CLDN1 in the maturation of the fibroblastic scars in IPF. Importantly, we provided a preclinical proof-of-concept for Lixudebart as a novel therapeutic approach based on the enrichment of exposed CLDN1 during disease progression and its association with epithelial injury and active fibrotic lesions in IPF lungs.
  • ||||||||||  lixudebart (ALE.F02) / Alentis Therap
    Phase classification, Enrollment change, Trial completion date, Trial primary completion date, Metastases:  FEGATO-01: A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis (clinicaltrials.gov) -  Mar 13, 2024   
    P1,  N=38, Recruiting, 
    Importantly, we provided a preclinical proof-of-concept for Lixudebart as a novel therapeutic approach based on the enrichment of exposed CLDN1 during disease progression and its association with epithelial injury and active fibrotic lesions in IPF lungs. Phase classification: P1b --> P1 | N=28 --> 38 | Trial completion date: Jun 2024 --> Nov 2024 | Trial primary completion date: Jun 2024 --> Nov 2024
  • ||||||||||  lixudebart (ALE.F02) / Alentis Therap
    Trial completion date, Trial primary completion date, Metastases:  FEGATO-01: A Clinical Trial of ALE.F02 in Patients With Advanced Liver Fibrosis and/or With Mild Cirrhosis (clinicaltrials.gov) -  Oct 30, 2023   
    P1b,  N=28, Recruiting, 
    Phase classification: P1b --> P1 | N=28 --> 38 | Trial completion date: Jun 2024 --> Nov 2024 | Trial primary completion date: Jun 2024 --> Nov 2024 Trial completion date: Jan 2024 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Jun 2024
  • ||||||||||  lixudebart (ALE.F02) / Alentis Therap
    Enrollment open:  Rescue of Nephrons With ALE.F02 (RENAL-F02) (clinicaltrials.gov) -  Oct 27, 2023   
    P2,  N=60, Recruiting, 
    Trial completion date: Jan 2024 --> Jun 2024 | Trial primary completion date: Jan 2024 --> Jun 2024 Not yet recruiting --> Recruiting
  • ||||||||||  lixudebart (ALE.F02) / Alentis Therap
    New P2 trial:  Rescue of Nephrons With ALE.F02 (RENAL-F02) (clinicaltrials.gov) -  Sep 21, 2023   
    P2,  N=60, Not yet recruiting,