XOMA Initiates U.S. Clinical Trial of Gevokizumab In Patients With Behcet's Disease Uveitis - EYEGUARD - US

XOMA Corporation

, a leader in the discovery and development of therapeutic antibodies, today announced that its EYEGUARD-US supplemental clinical study is open for enrollment to patients at study sites located in the United States. The objective of this trial is to assess the efficacy and safety of gevokizumab in treating Behçet's disease uveitis. "To ensure we designed a study that meets the needs of the U.S. clinicians treating patients who suffer from Behçet's disease uveitis, we worked closely with key opinion leaders to create a protocol that reflects how they treat patients with this serious disease," stated Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer of XOMA. "It was important that the study design allows for the inclusion of patients experiencing active inflammatory episodes, as well as patients who are currently under control but may benefit from an alternative therapy." The study is titled "A RandomizEd-Withdrawal, Double-Masked, Placebo-Controlled StudY of the Efficacy and Safety of GevokizUmAb in TReating Subjects with Behçet's Disease UveitiS" (EYEGUARD-US). Up to 28 patients will receive gevokizumab on an open-label basis to determine if they respond to therapy. At Day 28, those who respond to gevokizumab will be randomized, one to one, in a double-masked fashion to either gevokizumab 60 mg or placebo, dosed subcutaneously once monthly. The study's primary endpoint is the time to first ocular exacerbation following randomization. "Opening EYEGUARD-US is a crucial step in our strategy to pursue Behçet's disease uveitis as our first indication for gevokizumab in the U.S.," commented John Varian, Chief Executive Officer of XOMA. "This strategy makes us less dependent on our EYEGUARD-A and C studies in the broader non-infectious uveitis population, which continue to enroll more slowly than hoped. EYEGUARD-US is designed as a well-controlled study to supplement data from the Phase 3 EYEGUARD-B study being performed by our partner SERVIER outside the U.S. and the ex-U.S. data previously generated from two Phase 2 trials of Behçet's disease uveitis patients." Mr. Varian added, "Upon receipt of successful results from the EYEGUARD-B study, we plan to request a pre-BLA meeting with FDA. EYEGUARD-US is designed to supplement the Agency's need for information in U.S. patients, including potentially serving as a second pivotal study." More details on the study design can be found at www.clinicaltrials.gov.