Effimune has announced, the publication in leading scientific journals of three different studies confirming the efficacy of FR104 in new preclinical models, and suggesting that it could be a potent new treatment for rheumatoid arthritis and psoriasis.
The three studies confirm CD28 as an interesting target and FR104 as a potential tool in immune regulation. They demonstrate the effectiveness of the drug candidate in different preclinical models of autoimmune inflammatory diseases:
- Two models of skin inflammation similar to human psoriasis
- A model of joint inflammation associated with rheumatoid arthritis
A molecule in a Phase I clinical trial with numerous possible therapeutic indications
"These three publications, added to the two previously published articles this year, show the great potential of FR104 in immune regulation. A Phase 1 clinical study in humans has been underway since April with promising results in terms of the antagonistic activity of the molecule" explains Maryvonne Hiance Effimune' CEO, a "The preclinical proof of concept of the FR104 efficacy has now been made for applications in transplantation, multiple sclerosis, rheumatoid arthritis and most recently for psoriasis."
FR104 is a monoclonal antibody fragment which is a specific antagonist of CD28, a key element in the T-lymphocyte signalling pathway. FR104 blocks, in a targeted manner, the destructive function of effector T-cells but not the function of regulatory T-cells, thus promoting immune tolerance.
The article published in the Journal of Immunology shows the role of CD28 in controlling the memory T cell response and demonstrates that selectively blocking CD28 with FR104 also inhibits the long-term response of the memory cells. Blocking this cell type presage a real remission of the disease and not a mere reduction in its appearance.
n the article published in October 2015 in Experimental Dermatology, the authors demonstrate the efficacy of FR104 in a new model of skin inflammation close to human psoriasis. In collaboration with UMR INSERM 1064, a new model for preclinical validation was generated with a topical application of Aldara, a cream containing 5% Imiquimod. In addition to showing the efficacy of FR104, this new model which is more similar to the human disease can be used to test other therapeutic approaches to psoriasis.
The third article, published in November in the Clinical & Experimental Immunology, demonstrates the effectiveness of FR104 in a new collagen-induced pre-clinical model of rheumatoid arthritis. In collaboration with the primatology center of Rijswijk and the University of Groningen in the Netherlands, the authors conducted a comparative study of the efficacy of FR104 and Orencia® (abatacept), a standard treatment in rheumatoid arthritis. The results show at least equal efficiency of FR104 on symptoms and a better efficiency on disease markers with a different mode of action on immune cells suggesting longer-term effects on the disease.