FR-104 is under clinical development by OSE Immunotherapeutics 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 FR-104’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.

FR-104 overview

FR-104 is under development for the treatment of autoimmune disorders including, rheumatoid arthritis, multiple sclerosis, psoriasis, uveitis, graft versus host disease (GVHD) and prevention of transplantation rejection including kidney transplantation and stem cell transplantation. It is administered intravenously and subcutaneously. It is a monovalent pegylated Fab fragment of a humanised anti-CD28 monoclonal antibody. The drug candidate is a new molecular entity (NME).

OSE Immunotherapeutics overview

OSE Immunotherapeutics (OSE) is a biotechnology company that discovers and develops immunotherapy products against invasive and metastatic late-stage cancers. The company’s memopi technology is employed in studying the development of treatments for ovarian, colon, and breast cancer. It provides products such as tedopi and effi-7. OSE’s Effi-7 is in preclinical development and targets autoimmune diseases and transplantation. OSE’s tedopi stimulates cytotoxic killer T cells and relearns them to detect cancer cells to eliminate them. The company offers pipeline products such as OSE-172, OSE-703, FR104, and 0SE-127. It markets its products through its distribution network. OSE is headquartered in Nantes, Pays-de-la-Loire, France.

For a complete picture of FR-104’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.