Siplizumab is under clinical development by ITB-Med and currently in Phase II for Liver Transplant Rejection. According to GlobalData, Phase II drugs for Liver Transplant Rejection have a 50% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Siplizumab’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.

Siplizumab overview

Siplizumab is under development for the treatment of bone marrow transplant rejection and solid organ transplant rejection such as kidney transplant rejection, type 1 diabetes and liver transplant rejection. It is a humanized version of BTI-322. The therapeutic candidate is an anti-CD2 monoclonal antibody which acts by targeting T cell surface antigen CD2. It is administered through intravenous and subcutaneous route.

It was also under development for the treatment of plaque psoriasis, graft versus host disease (GVHD), T-cell lymphomas like peripheral, natural killer cell lymphomas, cutaneous lymphoma.

ITB-Med overview

ITB-Med (ITBMed) is a biopharmaceutical company that develops specific immunomodulatory biologics for organ and stem cell transplantation and gene therapy. Its lead product candidate, Siplizumab, a recombinant monoclonal antibody, binds to the human CD2 receptor molecule detected on T lymphocytes (T cells), natural killer cells, and thymocytes. The activation of T cells leads to transplant rejection in solid organ (kidney) and bone marrow transplantation patients. The unique mechanism of Siplizumab induces alloantigen hyporesponsiveness and has immunomodulatory effect, which down-regulates the rejection response and facilitates the discontinuation of immunosuppression treatment. It conducts research and development programs in scientific collaboration with Columbia University to advance its pipeline. ITBMed is headquartered in Stockholm, Sweden.

For a complete picture of Siplizumab’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.