KPL-404 is under clinical development by Kiniksa Pharmaceuticals and currently in the Phase I and 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 KPL-404’s likelihood of approval (LoA) and phase transition for Graft Versus Host Disease (GVHD) took place on 19 Jul 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their KPL-404 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

KPL-404 overview

KPL-404 is under development for the treatment of autoimmune diseases including T-cell-dependent, B-cell-mediated diseases, such as pemphigus/pemphigoid, myasthenia gravis, or graft versus host disease, sicca syndrome, systemic lupus erythematosus, rheumatoid arthritis, type 1 diabetes, ulcerative colitis, lupus nephritis, hidradenitis suppurativa, transplant rejection of heart, pancreatic islet and kidney, idiopathic thrombocytopenic purpura. It is administered through intravenous or subcutaneous route. The drug candidate is a monoclonal antibody. It acts by targeting CD40.

It was also under development for the treatment of focal segmental glomerulosclerosis (FSGS).

Kiniksa Pharmaceuticals overview

Kiniksa Pharmaceuticals (Kiniksa) is a biopharmaceutical company that discovers, acquires, develops and commercializes medicines to treat autoinflammatory and autoimmune diseases. The company’s pipeline product portfolio includes Rilonacept drug for the treatment of recurrent pericarditis; mavrilimumab, against giant cell arteritis, COVID-19 and hyper inflammation; vixarelimab, targeting prurigo nodularis and diseases characterized by chronic pruritus; KPL-404, a monoclonal antibody to treat T-cell dependent, B-Cell–mediated indications. It develops medicines in the therapeutic areas of cardiovascular, dermatology and autoimmune diseases. The company has an operational presence in Massachusetts and California, the US; and London, the UK. Kiniksa is headquartered in Hamilton, Bermuda.

Quick View KPL-404 LOA Data

Report Segments
  • Innovator
Drug Name
  • KPL-404
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Dermatology
  • Gastrointestinal
  • Genito Urinary System And Sex Hormones
  • Hematological Disorders
  • Immunology
  • Metabolic Disorders
Key Developers
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.