Eisai Co Ltd. announced that interim analyses on the latest data for the world’s first anti-fractalkine monoclonal antibody E6011, discovered by Eisai’s research subsidiary KAN Research Institute Inc. from two respective Phase I/II clinical studies in Crohn’s disease and rheumatoid arthritis (Study 101 and Study 103) showed positive results for safety and tolerability, and exploratory assessment suggested clinical activity for E6011. These data have been presented at a number of recent academic conferences.
Study 101 is a multicenter, open-label study to evaluate mainly the safety and tolerability of E6011 in 21 Japanese patients with Crohn’s disease who respond inadequately to conventional therapy which includes anti-tumor necrosis factor (TNF) therapies. The results of Study 101 were presented at Digestive Disease Week 20161 in May.
Study 103 is a multicenter, open-label study to evaluate mainly the safety and tolerability of E6011 in 27 Japanese patients with rheumatoid arthritis who respond inadequately to methotrexate or anti-TNF therapy. The results of study 103 were presented at the American College of Rheumatology (ACR) Annual Meeting2 in November 2015, the Annual General Assembly and Scientific Meeting of the Japan College of Rheumatology3 in April 2016 and the Annual European Congress of Rheumatology EULAR 20164in June. Additionally, the presentation on the results of Study 103 was accepted as a late-breaking abstract for the ACR Annual Meeting 2015.
Fractalkine is expressed on the surface of vascular endothelial cells in patients with inflammatory diseases including rheumatoid arthritis and inflammatory bowel diseases, and is involved in inflammatory response when bound to fractalkine receptors (CX3CR1) expressed in immune cells. E6011 is an antibody therapy with a novel mechanism of action, and is believed to exhibit an anti-inflammatory effect by suppressing the migration and invasion of CX3CR1-positive immune cells.
Eisai is striving to accelerate the development of E6011 as a key product to contribute to improving the benefit for a greater number of patients and their families.
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1 Matsuoka K, et al., Safety, Tolerability and Efficacy of E6011, Anti-Human Fractalkine Monoclonal Antibody, in the First-Patient Study for Crohn’s Disease, Digestive Disease Week 2016, Poster Number Mo1890.
2 Tanaka Y, et al., Safety and Efficacy of E6011, an Anti-Fractalkine Monoclonal Antibody, in a First-in-Patient Phase 1/2 Study in Rheumatoid Arthritis. ACR 2015. Late-breaking Abstract Number 13L
3 Tanaka Y, et al., Safety, Pharmacokinetics and Efficacy of E6011, an Anti-Fractalkine Monoclonal Antibody, in a First-in-Patient Phase 1/2 Study in Japanese Patients with Rheumatoid Arthritis. 60th Annual General Assembly and Scientific Meeting of the Japan College of Rheumatology 2016. Poster Number ICW-C15-5.
4 Tanaka Y, et al., Safety and Efficacy of E6011, an Anti-Fractalkine Monoclonal Antibody, in a First-in-Patient Phase 1/2 Study in Rheumatoid Arthritis. EULAR Annual European Congress of Rheumatology 2016, Poster Number FRI0236
5 Data from the Japan Intractable Disease Information Center: http://www.nanbyou.or.jp/entry/81
6 World Health Organization, Chronic Rheumatic Conditions: http://www.who.int/chp/topics/rheumatic/en.
