BTG Drug Developed By Glaxo And Tolerx Misses Study End Point

GlaxoSmithKline PLC (GSK) and U.S. partner Tolerx, Inc. said Friday their experimental drug otelixizumab failed to achieve its target in a late-stage clinical trial for Type 1 diabetes.

The two companies in a joint statement said otelixizumab, an investigational anti-CD3 monoclonal antibody for treating adults with newly diagnosed Type 1 diabetes, did not meet the primary endpoint set for a Phase III study named DEFEND-1.

Glaxo said it plans to explore additional dosing regimens in the light of the outcome. New recruitment and dosing in a second similar clinical study named DEFEND-2 has been suspended pending review of the results.

Otelixizumab is being developed in collaboration with Glaxo and Tolerx. The drug candidate is licensed in from U.K.-based BTG PLC (BGC.LN).

Louise Makin, BTG's chief executive, said in a statement that "the result of the DEFEND-1 study is obviously disappointing, though we note that GSK is continuing development of otelixizumab in autoimmune diseases."

Glaxo and Tolerx in Oct. 2007 set up alliance to develop and commercialize otelixizumab for a range of autoimmune and immune-mediated inflammatory diseases, including type 1 diabetes.

Under the deal, Tolerx is responsible for the clinical and regulatory activities for otelixizumab in type 1 diabetes in the U.S. and has the option to co-promote otelixizumab in type 1 diabetes in the U.S. with Glaxo, while the U.K. drug maker has exclusive rights to develop and commercialize otelixizumab in all other indications in the rest of the world. Glaxo also has the exclusive right to develop the pediatric indication for type 1 diabetes in the U.S.

-By Sten Stovall, Dow Jones Newswires; [phone]; [e-mail]