Imlifidase is under clinical development by Hansa Biopharma and currently in Phase III for Autoimmune Disorders. According to GlobalData, Phase III drugs for Autoimmune Disorders have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Imlifidase’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. 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 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’s disease), limb-girdle muscular dystrophy, duchenne muscular dystrophy and pompe disease. 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.


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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.