Nadav Kidron is a man with a vision.
His goal: to create consumer-ready insulin capsule that can be ingested orally, currently in advance clinical-stages of development by his company, Oramed Pharmaceuticals (NASDAQ: ORMP).
Nadav servs as CEO of the Jerusalem based pharmaceutical company, which he co-founded in 2006 to help make a discovery by his mother, Miriam – a researcher at Hadassah-Hebrew University Medical Center – available to the public.
“My father suffered from diabetes and it was my mother’s mission to find an alternative way to deliver insulin,” said Kidron. “When she told me that they had a breakthrough that could help millions of people around the world, that’s when I knew I had to make it a reality.”
With a degree in Law and an MBA from Bar Ilan University, Kidron is a member of the Israeli bar, an international lecturer on Israel’s entrepreneurial culture, and has senior executive experience in a wide range of industries.
Before the advent of insulin injections, diabetes-related deaths were much more frequent and unavoidable. Injections have been a big step forward, but the ability to ingest an insulin pill orally would allow for increased safety, compliance and overall convenience. The increased quality of life that comes from taking a pill instead of injecting oneself means that many people who are reluctant to treat their diabetes and wait until their condition deteriorates, would do so sooner and nip many potential complications in the bud.
“Not only does oral insulin offer a more convenient alternative to needles, a therapy many patients are reluctant to begin,” says Kidron. “It also provides a more efficient and safer platform for delivering insulin by mimicking the body’s natural process of insulin via the liver rather than directly into the bloodstream.”
Doctors are often reluctant to prescribe insulin injections because it relies on vigilant patient compliance and can result in accidentally injecting too much insulin which can have deadly sideeffects. In addition,, since the injectable insulin must travel through the bloodstream before reaching the liver it often results in excess sugar being stored in fat and muscles, resulting in weight gain. Because of this, insulin injections are almost exclusively used as a last resort in diabetes care.
Several companies have tried, and failed, to create an insulin pill that prevents the insulin from breaking down in the gastrointestinal system, delaying its distribution until it reaches the bloodstream where it reduces blood glucose levels.
Based out of Jerusalem, Oramed is the first company to successfully create a pill that protects the insulin until it reaches the bloodstream. It does this by creating a capsule with pH sensitive coating that protects the pill from the stomach’s acidity until it reaches the small intestine. There, it is actually designed to permeate the intestinal membrane with increased effectiveness, increasing the amount of insulin actually delivered into the bloodstream.
In 2017, Oramed launched the largest and most advanced clinical trials to date under the direction of the FDA, involving 240 patients with type 2 diabetes in multiple centers throughout the United States. Trial participants will take the oral pill for 90 days, with their blood sugar levels being closely monitored to test the drug’s efficacy. Results of the study are expected to be released mid-next year.
With over 415 million people in the world living with diabetes (>100 million in the US alone), and another 227 million expected over the next few decades, the market need is huge. Over one eighth of the entire global healthcare expenditure goes to the treatment of diabetes – over $673 billion in 2015 alone.
If the results of the 2017 studies come back successful, final phase trials can be initiated in 2019/20, allowing the treatment to finally be brought to market.
But Oramed isn’t just limiting itself to the US market. It is already looking to initiate a Phase 3 trial in China, under the Chinese FDA supervision. In 2015, a Chinese company, HTIT, entered into an exclusive licnese with Oramed for $50 million plus 10% royalties on net sales in Greater China
As companies worldwide rush to create an oral insulin pill, Oramed seems poised to be the company that administers the breakthrough, changing the lives of millions of diabetics around the world.