Do you exercise at least three times a week? Does your diet consist of mostly vegetables, fruit and fiber? If not, you are part of a high-risk group for type 2 diabetes. If you do have the condition, you will definitely not be alone: According to the World Health Organization (WHO) 347 million people worldwide suffer from diabetes, and the number could near 600 million by 2035.
To date, the only way of treating type 2 diabetes is by injecting insulin. But there are two medical companies racing in the development of an insulin pill, which could make it easier for sufferers to start early treatment, slow progression of the disease, reduce risks of side-effects, such as blindness, and delay the need for injections.
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One of these companies is Danish pharmaceutical giant Novo Nordisk, and the other is a small Tel-Aviv based company called Oramed.
Despite its proportional disadvantage, the Israeli startup is currently one step ahead: Its phase two clinical trials were declared a success by the Food and Drugs Administration in the United States.
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The concept of oral insulin as a way to relieve diabetics of daily injections has been around for decades, but making it happen is extremely difficult because insulin is destroyed by enzymes in the digestive system. Moreover, while many diabetics have grown accustomed to injecting themselves, or use a pump which injects the insulin automatically, a major issue is regulating the steady amount of insulin in the blood, which simply cannot be done with external injections.
Oramed believes that it has now found a solution to allow enough insulin to survive through the digestive system to still do some good.
Beating the obstacles
Insulin is meant to reach the liver, which regulates the secretion of insulin into the bloodstream. Unlike injections, the ingested form passes directly into the liver from the digestive tract.
CEO Nadav Kidron says oral insulin pills are also more financially beneficial. According to him, $500 billion is spent annually on diabetes treatment. “Even a small percentage of cost reduction will make a big economical difference,” he says.
A platform for vaccines in pill form
The next year-long Phase IIb study in the United States will study 150 type 2 diabetes patients and mainly test for the drug’s effectiveness.
Oramed, which has so far raised $34 million will also need to conduct a final large-scale Phase III trial before the drug is licensed for sale, so the capsule is still years away from entering the market. The company is, however, ahead of Novo Nordisk, which has yet to start Phase II testing.
Oramed is hoping to partner with large pharmaceutical firms for development and sales of the drug.
In addition, Kidron believes his company’s unique oral delivery technology “serves as a platform for other vaccines and medications currently available in injection form.”
Oramed is endorsed and directed by prominent leaders in the field of research and development, including: Professor Avram Hershko, 2004 Nobel Prize Laureate in Chemistry; Professor John Amatruda, former Senior Vice President of Merck and Co., Inc.; Professor Ele Ferrannini, past President of the EASD; and Dr. Michael Berelowitz, former SeniorVice President at Pfizer, Inc., and currently the Chairman of the Oramed Scientific Advisory Board.