XBiotech treats first patient in Phase II RA trial of Natrunix

XBiotech began treating the first patient in a phase II, double-blind, placebo-controlled, randomized clinical study to evaluate Natrunix as a new treatment for Arthritis. Natrunix blocks a key cause of inflammation involved in pain and joint destruction in rheumatoid arthritis. The primary endpoint of the Phase II is the American College of Rheumatology 20% Response rate at 12 weeks. Secondary and exploratory endpoints include ACR 50, ACR 70, numerical rating scale for pain score, inflamed and painful joint counts, Health Assessment Questionnaire Disability Index, Routine Assessment of Patient Index Data 3, Clinical Disease Activity Index and safety. These endpoints reflect the expectation that Natrunix may provide needed improvement with respect to pain, tenderness, mobility of joints and quality of life. Approximately 210 subjects will be enrolled into three different arms in the study. All subjects will receive methotrexate and be randomized to receive either one of two doses of Natrunix or placebo. Natrunix is a monoclonal antibody indistinguishable from a naturally occurring antibody from a human donor. Natrunix binds and neutralizes the action of one of the most potent inflammation-causing substances known-interleukin-1. For decades, interleukin-1 was seen as the key target for drugs to treat RA. However, to date, drugs that block interleukin-1 have not lived up to expectations as therapies for RA.