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For decades, the only option for patients with Type 1 diabetes has been insulin injections used as a hormone to control sugar metabolism. But such treatment produces inconsistent therapeutic results and fails to prevent the deadly, long-term complications of the disease.

AutoImmune's AI-401 is an oral or nasally delivered formulation of recombinant human insulin for the prevention of diabetes. Its therapeutic principle is to selectively suppress the body's attack on its own insulin-producing cells, and thereby slow or prevent disease progression. Proof of concept has been demonstrated in animal models, and a successful Phase I trial or oral insulin found the product to be safe.

Eli Lilly and Company supported three different clinical trials of oral insulin involving a total of more than 350 newly diagnosed patients to see if disease progression can be modified. The studies in France and Italy showed no benefit, but looked primarily at younger patients. The US study which reported positive results for patients age 20 and greater has been published.

In April 1999, AutoImmune and Eli Lilly restructured their agreement on AI-401. Under the restructured agreement, Eli Lilly received a non-exclusive research license to complete the studies of AI-401 and agreed to provide AutoImmune with full access to the clinical data. AutoImmune has regained control of all rights to the product and the underlying technology.

Separately, the National Institutes of Health conducted a large-scale study, called the Diabetes Prevention Trial-1 (DPT-l), to determine if small doses of insulin (oral or subcutaneous) can prevent the onset of Type 1 diabetes in people at risk for developing the disease within five years. Lilly provided the insulin for this trial. The final results of this study were published during 2005 and show a statistically significant benefit for patients in the oral insulin group who were enrolled under the original study entry criteria. The NIH is currently in the planning stages for a confirmatory trial.

There is also ongoing in Finland a clinical trial of intranasal insulin to delay or prevent the clinical onset of Type I diabetes (Diabetes Prediction and Prevention Project = DIPP).

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