Parallel U.S. Phase III trial is due to report final results in mid-2012.
Diamyd Medical’s antigen-based type 1 diabetes therapy Diamyd® failed to meet its primary endpoint in a 320-patient European Phase III trial. The study in newly diagnosed patients showed that the treatment had no significant benefits in terms of preserving beta cell function at 15 months, although a small positive effect was seen, the firm notes.
Patients enrolled in the trial will continue to be followed for a further 15 months to evaluate safety and efficacy. Meanwhile, a parallel U.S. Phase III study, DiaPrevent, is expected to report during mid-2012. The potential for Diamyd therapy to prevent type 1 diabetes developing in high risk patients is separately being evaluated in a Phase II study.
The firm admits it “had hoped for a better outcome” from the European Phase III study, but said it will further analyze the study results together with data from ongoing studies. The European trial involved patients who had been diagnosed with type 1 diabetes three months or less prior to enrollment. Participants were randomized to receive either four subcutaneous injections of Diamyd over 270 days, or two Diamyd injections at day 1 and day 30, or placebo.
Antigen-based Diamyd therapy comprises the human GAD65 protein, and is designed to delay or halt the GAD-targeted autoimmune attack on beta cells that characterizes type 1 diabetes and other forms of autoimmune diabetes, Diamyd explains. A previous Phase II study in children and adolescents found the treatment significantly slowed the progression of disease in patients who were treated within 18 months of initial diagnosis.
During mid-2010 Diamyd inked a $45 million up-front deal with Ortho-McNeil-Janssen Pharmaceuticals (OMJP) for the development and commercialization of Diamyd. The firms have been co-funding continued development of the candidate up to the release of results from the Phase III European trial. OMJP has an option to take over global development of Diamyd, pending its review of the trial data.