Siplizumab is under clinical development by ITB-Med and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Siplizumab’s likelihood of approval (LoA) and phase transition for Kidney Transplant Rejection took place on 31 Mar 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Siplizumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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.

Quick View Siplizumab LOA Data

Report Segments
  • Innovator
Drug Name
  • Siplizumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Immunology
  • Metabolic Disorders
  • Oncology
Key Developers
  • Sponsor Company: ITB-Med
  • Originator: Catholic University of Louvain
Highest Development Stage
  • Phase II

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.