Combo-happy Diamyd launches new diabetes vaccine trial in children

Lead investigator Helena Elding Larsson

Diabetes vaccine developer Diamyd Medical has faced its fair share of setbacks in the past, but that hasn't stopped the Swedish company from launching multiple clinical trials to assess the promise of its candidate, Diamyd. The latest: A Phase II test to see if the prospect can prevent or delay the onset of Type 1 diabetes in children at very high risk of presenting with the disease.

For the study, dubbed DiAPREV-IT2, researchers have drafted the first participant out of what will be a group of 80 children in whom the autoimmune process leading to Type 1 diabetes has already started. Once enrolled, half the children will receive two injections of Diamyd, while half will receive a placebo. Over the 5-year course of the study, children from either group who develop symptomatic Type 1 will receive Diamyd injections after diagnosis to monitor its effects on new onset patients, the company said.

"It is very satisfying to be able to offer these children a study with the aim of preventing or delaying the disease process," lead investigator and study sponsor Helena Elding Larsson said in a statement.

But unlike complementary study DiAPREV-IT, children participating in DiAPREV-IT 2 will also receive vitamin D, which the team hopes will strengthen the vaccine's efficacy. In all four of Diamyd's other ongoing studies, the company has set the jab up as part of combos that include vitamin D, etanercept, ibuprofen or other components.

That's no coincidence. Diamyd has already failed a Phase III study on its own, and that 2011 event led then-partner Johnson & Johnson ($JNJ) to hand back a stake in the vaccine it had purchased the year prior. Other competing firms also reported less-than-stellar results in Phase III trials between 2010 and 2012, Diamyd said, which prompted it to look into combos.

Since then, the company has seen some new backing. Last August, the EU awarded it a €120,000 grant for a study evaluating whether vitamin D and ibuprofen help the vaccine preserve the insulin-producing capacity in children newly diagnosed with Type 1 diabetes. And in September, it bolstered a longtime pact with Protein Sciences, which agreed to use its BEVS technology to manufacture Diamyd's GAD protein for further studies.

- read Diamyd's release