KPL-404 is under clinical development by Kiniksa Pharmaceuticals and currently in Phase II for Rheumatoid Arthritis. According to GlobalData, Phase II drugs for Rheumatoid Arthritis have a 32% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how KPL-404’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.

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.

For a complete picture of KPL-404’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.