EYEGUARD-C is designed to enroll 300 patients worldwide. They will be randomized to receive either doses of gevokizumab or placebo, monthly for twelve months. All patients will undergo a predetermined reduction in their steroid doses. The study's primary endpoint is the proportion of patients with an occurrence of uveitic disease through Day 168. The study also will assess other important measures of improvement in their uveitic disease including the reduction of steroid use.
Paul Rubin, M.D., XOMA's Senior Vice President of Research and Development and Chief Medical Officer, stated, "It was a natural decision to expand the required safety study to a full efficacy trial, particularly in the NIU patient population. Long-term treatment with corticosteroids is detrimental to the patient's overall health, and the immunosuppressants being used today put the patient at significant risk of infection. We believe our antibody may be able to prevent acute exacerbation of the disease and allow physicians to reduce or even eliminate the use of corticosteroids and other immunosuppressant medications."
SERVIER (Suresnes, France), XOMA's partner jointly developing gevokizumab and holding rights outside the U.S. and Japan for the NIU indication, hails this additional entry into Phase 3 for gevokizumab. "NIU is a very debilitating disease with no therapeutic options beside potentially harmful long-term corticotherapies. Servier is very delighted by this important step in the clinical development of gevokizumab, which may ultimately prove its clinical value in inflammatory diseases," said Isabelle Tupinon-Mathieu, M.D., Head of Therapeutic Research and Development at Servier.
Conference Call and WebcastXOMA will host a conference call and webcast today, October 3, 2012, at 4:30 p.m. ET. The webcast can be accessed via the Investors & Media section of XOMA's website at http://investors.xoma.com/events.cfm and will be available for replay until close of business on January 3, 2013. Telephone numbers for the live audiocast are (877) 369-6589 (U.S./Canada) and (408) 337-0122 (international). A telephonic replay will be available beginning approximately two hours after the conclusion of the call until October 7, 2012. Telephone numbers for the replay are (855) 859-2056 (U.S./Canada) and (404) 537-3406 (international), passcode 36952162.