Phase III trial of gevokizumab expanded

Berkeley, CA-XOMA Ltd. and its partner, Les Laboratoires Servier, plan to implement a broader phase III program to test the monoclonal antibody gevokizumab, or XOMA 052, in patients in whom non-infectious uveitis (NIU) involving the intermediate and/or posterior segments of the eye has been diagnosed.

NIU is a clinical designation that encompasses multiple ocular diseases, including Behçet’s uveitis. Expanding the trial will increase its potential U.S. patient population from the estimated 7,500 patients with Behçet’s uveitis to an estimated 150,000 patients with NIU.

“The clinical team has worked diligently to assess the therapeutic potential for gevokizumab in NIU in an effort to maximize the value of our uveitis opportunity, particularly in the United States. We also wanted to pinpoint additional clinical indications where there is a clear medical need to expand the commercial potential of gevokizumab,” said John Varian, interim chief executive officer of XOMA. “We remain fully committed to bringing gevokizumab to patients with Behçet’s uveitis, as they are in need of new therapeutic options, and to additional patients in the broader NIU indication.”

XOMA recently held an end-of-phase-II meeting with the FDA to discuss its revised development strategy for gevokizumab in NIU. Based on these discussions, XOMA intends to use the results of two planned studies, one in NIU and a second in the Behçet’s uveitis subset of NIU, to form the basis of a license application in support of an NIU indication. XOMA will manage the U.S. clinical sites for the NIU study.

The planned study designs will be presented to the European Medicines Agency (EMA) to obtain its input before the trial begins. Assuming successful completion of the necessary discussions with EMA, the company anticipates implementation of the program in the second quarter of 2012. XOMA expects the relatively large number of NIU patients should enhance the pace of enrollment.

“Both Behçet’s uveitis and NIU are orphan indications with limited therapeutic options consisting primarily of corticosteroids and immunosuppressive drugs,” said Paul Rubin, MD, XOMA’s vice president, clinical development and chief medical officer. “The inflammation seen in NIU, independent of its etiology, is linked strongly to the presence of interleukin (IL)-1-beta, as it is in Behçet’s uveitis. These observations support our decision to expand this program, which we believe will generate interest from the ophthalmology and rheumatology communities.”

XOMA also announced the initiation of a proof-of-concept program that is designed to evaluate gevokizumab’s therapeutic potential in additional inflammatory diseases with documented IL-1-beta involvement.

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