Imlifidase is under clinical development by Hansa Biopharma and currently in Phase III for Goodpasture Syndrome (anti-Glomerular Basement Membrane Disease). According to GlobalData, Phase III drugs for Goodpasture Syndrome (anti-Glomerular Basement Membrane Disease) does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Imlifidase LoA Report. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Imlifidase overview
Imlifidase (Idefirix) is an immunosuppressive agent. It is formulated as powder for concentrate for solution for intravenous route of administration. It is a unique IgG antibody-cleaving enzyme indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor.
Imlifidase is under development for the treatment of antibody mediated rejection of HLA sensitized kidney after transplantation, acute autoimmune diseases including Guillian-Barre syndrome, anti-glomerular basement membrane (anti-GBM) disease (Goodpasture Syndrome), anti-neutrophil cytoplasmic antibodies (ANCA) associated vasculitis, granulomatosis with polyangiitis, microscopic polyangiitis, acute respiratory distress syndrome and pulmonary alveolar hemorrhage. IdeS (Immunoglobulin G-degrading enzyme of Streptococcus pyogenes) is recombinantly produced immunoglobulin G-degrading enzyme of S.pyogenes.
It was also under development for the treatment of asymptomatic antibody-mediated thrombotic thrombocytopenic purpura.
Hansa Biopharma overview
Hansa Biopharma focuses on the development of novel immunomodulatory enzymes for transplantation, gene therapy, cancer and acute autoimmune diseases. The company’s lead project, imlifidase is a proprietary antibody cleaving enzyme for kidney transplant patients which is protected by 6 patent families. Its preclinical assets include NiceR for recurring treatment in autoimmune disease, transplantation, and cancer; and EnzE, cancer immunotherapy. Hansa Biopharma offers a novel diagnostic method HBP-assay (serum quantification of Heparin Binding Protein) to help predict severe sepsis in patients with infectious disease symptoms. The company has out-licensed its HBP-assay (serum quantification of Heparin-Binding Protein), a novel diagnostic method to help predict severe sepsis in patients with infectious disease symptoms to Axis-Shield Diagnostics. It has its operations in Other European Countries and the US. Hansa Biopharma is headquartered in Lund, Sweden.
For a complete picture of Imlifidase’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
