Twenty-five years of research and a great deal of pure determination has brought the dream of an oral insulin pill to reality for Hadassah’s Dr. Miriam Kidron. The challenge has been the fact that insulin, a hormone that helps controls glucose levels in the body, breaks down in the digestive system, making absorption of insulin into the blood circulation weak, and the idea of effective oral insulin tablets difficult to imagine. Yet, Oramed Pharmaceuticals, the company that Kidron’s son Nadav founded in 2005 to commercialize her research, is now in the midst of Phase I clinical trials at Hadassah for what promises to be the world’s first oral insulin treatment for Type 2 diabetes. 

The World Health Organization (WHO) estimates that the number of people suffering from diabetes worldwide now stands at 200 million, and predicts that this figure will rise to 370 million by 2030. Of this number, 90 percent have Type 2 diabetes.

“Once patients come to a doctor with high glucose in their blood, it’s only a matter of time before they start taking medication,” says Mr. Kidron, Oramed’s Chief Executive Officer. The medication, compensating for the body’s lack of sufficient insulin production, causes the pancreas to produce more insulin. But this overworks a system that is already not working very well, Kidron explains, and at the end of the day, the pancreas just can’t cope. Gradually, the pancreas loses its ability to produce any insulin. That’s when insulin injections become necessary.

The benefit of the Oramed insulin capsule is that it is an orally ingestible softgel that has been specially engineered to protect the insulin from the destructive effects of gastric juices. The insulin it delivers goes straight to the liver, which stores insulin and controls the dose being delivered to the body.

Mr. Kidron explains: “When you inject insulin, it goes straight to the bloodstream and the liver has no control over it. In our case, the liver only releases the amount of insulin that the body needs. Our insulin complements the insulin that the body is naturally able to produce, so that a patient never becomes insulin dependent. It mimics the physiological delivery of insulin. It’s a real revolution.”

Oramed believes the capsule can replace existing medications used by Type 2 diabetics early in their disease, and thus preserve and possibly enhance pancreatic and liver function. “Hopefully they will never have to inject insulin because this capsule will help them control insulin levels for the rest of their lives,” he says.

If the results from the Phase I clinical studies are as good as they expect them to be, Kidron states, “within three years we will have a product out there that’s working very well. This is a very short time to market and a very exciting development for the industry.”