Gevokizumab fails to meet primary endpoint in phase 3 trial for Behçet’s disease uveitis

Xoma today announced gevokizumab failed to meet its primary endpoints in a phase 3 trial in patients with uveitis caused by Behçet’s disease, according to a company press release.

The EYEGUARD-B study — a randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with Behçet’s disease uveitis — enrolled 83 patients with Behçet’s disease uveitis, with 40 patients randomly assigned to receive gevokizumab and 43 patients assigned to receive placebo. The primary endpoint was time to the first acute ocular exacerbation.

“Although the study did not achieve its main objective, we did see signals of drug activity such as preserved visual acuity, less severe ocular exacerbations and a reduced incidence of reported macular edema in patients treated with gevokizumab,” Paul Rubin, MD, senior vice president of research and development and chief medical officer for Xoma, said in the release. “We will continue to work closely with our partner, Servier, and uveitis experts to conduct a thorough analysis of the data to fully understand gevokizumab’s impact on several clinically relevant endpoints.”

In a conference call, John Varian, CEO of Xoma, said patients who received placebo did not exhibit expected disease behaviors.

“We are truly shocked and surprised that this study did not result in a positive outcome,” Varian said. “The placebo patients did not behave in the manner every expert with whom we’ve consulted and every paper we’ve read would have predicted. Based on the natural history of the disease, no one expected patients to just get better at the 5 mg dose of corticosteroids they received, but somehow, they did.”

According to Varian, nearly 40% of patients enrolled at 9 months did not have an exacerbation, which indicates that more research into the effects of gevokizumab is warranted.

Reference : www.xoma.com.