MLN3897 is one of several small molecules included in the company's small molecule inflammation collaboration with sanofi-aventis. MLN3897 is a small molecule antagonist of CCR1, a chemokine receptor found on the surface of various cells in the immune system and involved in a number of inflammatory disorders.
The study will assess the efficacy, safety and tolerability of MLN3897 in combination with methotrexate, a standard therapy for rheumatoid arthritis. The primary endpoint of the study will be improvement in the number of tender and swollen joints and various levels of disease activity.
“Although many patients with rheumatoid arthritis initially respond to standard disease-modifying antirheumatic drugs such as methotrexate or anti-tumor necrosis factor drugs to some degree, up to 70% ultimately have an inadequate response,” said Nancy Simonian, senior vice president, Clinical, Medical and Regulatory Affairs, Millennium.
In the phase I studies, results showed MLN3897 to be well-tolerated and to exhibit dose dependent blockage of the CCR1 receptor. Since CCR1 is involved in the recruitment of white blood cells in response to sites of inflammation, effectively blocking CCR1 could have a significant effect on rheumatoid arthritis disease progression.