Diabetes is a growing concern world-wide with studies showing some 425 million adults have diabetes globally and that number is expected to reach 629 million by 2045. Now, oral insulin – the Holy Grail of diabetes care that has eluded researchers for decades, yet could improve the way diabetes is treated – is taking a major step towards becoming reality.

Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, is working to bring the first oral insulin product to market, potentially providing a more convenient, effective and safer method for delivering insulin therapy.

The company has launched its largest and most advanced clinical trial under direction of the U.S. Food and Drug Administration (FDA) to date, involving approximately 285 patients with type 2 diabetes in multiple centers throughout the U.S.

Oramed’s oral insulin is currently in a pivotal clinical study going through FDA regulatory channels and would be a game-changer for the more than 100 million American adults living with diabetes or prediabetes.

The company has also signed a licensing deal with HTIT, a Chinese pharmaceutical company that is now working with Oramed to bring oral insulin to China.  More than 10 percent of the Chinese adult population suffers from diabetes, and like other areas of the world, this trend is only increasing, with some 50 percent of the adult Chinese population estimated to be prediabetic. Working with the China Food and Drug Administration to gain approval, HTIT is investing hundreds of millions of dollars into building the infrastructure to bring oral insulin to China.

Kidron explained that early insulin therapy is ideal in order to decrease the burden on a diabetic’s pancreas, potentially allowing it to continue producing insulin for longer – a position that is endorsed by the American Diabetes Association. However, he said doctors are often cautious when prescribing insulin by injection because it is a complex process that relies on patient compliance. Not only is there a danger of injecting too much insulin, but because the insulin is introduced directly into the bloodstream, only a fraction reaches the liver, often causing excess sugar to be stored in fat and muscle which results in weight gain. For this reason, injectable insulin is often viewed as a last resort.

“Our oral insulin could solve the drawbacks to injectable insulin, delivering it in a way that a needle could never replicate,” said Oramed CEO Nadav Kidron. “Not only does oral insulin offer a more convenient alternative to needles, a therapy many patients are reluctant to begin, but it also provides a more efficient and safer platform for delivering insulin by mimicking the body’s natural process of insulin going directly to the liver rather than via the bloodstream.”

With Oramed’s proprietary platform, the active insulin is protected as it travels through the stomach and into the intestine, and its absorption is increased along the intestinal wall. The result is better glucose control, reduced hyper and hypoglycemia, and less weight gain. In addition, oral insulin is easier for diabetics to incorporate into their daily routine because they simply take a pill.

“Right now, we know there are diabetics who would benefit with early insulin therapy who are simply not getting it due to the fact that, today, it is only available as an injection,” Kidron said. “By providing insulin in an effective pill form, we’re removing the barriers from both the physician and patient perspectives.”

The trial participants will take the oral pill for 90-days, with different groups following different dosing regimens at varying times throughout the day. The study is designed to show the product’s effectiveness at lowering glycated hemoglobin, a determinant of average blood sugar levels over three months and is considered the gold standard by the FDA when evaluating the drug’s efficacy.

An earlier trial for Oramed’s oral insulin – involving 180 patients across the U.S. over 28 days – demonstrated strong promise for the technology, showing it to be a safe oral insulin delivery method with no serious adverse events related to the treatment. It also indicated a significant ability to lower glucose levels, including the glycated hemoglobin gold standard. The current trial – the first to be conducted over 90 days – is hoped to show an even greater impact.

“This is our most important study to date,” Kidron said. “A year from now we will better know the potential of our drug to control and maintain blood glucose levels and will have further proof of the longer-term benefits of taking an oral insulin pill earlier on in the treatment.”