Groundbreaking insulin pill nearing market

For 100 years, scientists searched for a way to deliver insulin orally instead of by injection. Now an Israeli team claims it’s found the solution. Phase 2 clinical trials are coming.

Swallowing a pill is much more palatable for diabetics than getting an injection. Photo via Shutterstock

Swallowing a pill is much more palatable for diabetics than getting an injection. Photo via Shutterstock*

Jerusalem’s Oramed Pharmaceuticals is one step closer to putting a groundbreaking oral insulin capsule on the market for people with Type 2 diabetes. The company is about to begin Phase 2 clinical trials on 147 people at about a dozen medical centers in the United States.

CEO Nadav Kidron tells ISRAEL21c that the company’s flagship product could revolutionize the treatment of diabetes, which now affects more than 371 million people worldwide and is the seventh leading cause of death in the United States. Most cases are Type 2, where the body does not use the hormone insulin effectively to metabolize sugars.

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The current method of self-injecting insulin is unpleasant and also carries the constant risk of infection. A capsule taken by mouth would be more convenient and also more natural, as it would mimic insulin’s normal route in the body. But until now nobody had found a way to orally deliver large-molecule polypeptides such as insulin and vaccines.

Israel is a major center for diabetes research, and in fact the technology underlying Oramed is based on 25 years of research at Hadassah University Medical Center in Jerusalem by scientists including Kidron’s mother, Dr. Miriam Kidron.

“After the breakthrough, we sat and talked about how it could help millions, but to do that you need to establish a company and get it financed,” Kidron relates. “I’m a lawyer with an MBA, so I started the company and raised the money nearly eight years ago.” The elder Kidron is chief medical and technology officer of the publicly owned Oramed, and Hadassah is a stakeholder.

“When they initiated this project almost 30 years ago at Hadassah, trying to get insulin delivered orally looked almost impossible,” says Kidron. “Today it’s just a matter of time till it’s on the market.”

Insulin capsule can slow the progression of diabetes

Kidron explains that Oramed’s management decided to focus solely on insulin not only because of the founding scientists’ expertise in diabetes research, but also because insulin levels are quite easy to measure in the blood.

And from a business standpoint, diabetes represents a giant market. Some $471 billion was spent worldwide last year to treat diabetes, and the International Diabetes Foundation estimates that by 2030, some 552 million people in the world will be diagnosed with the disease.

Most importantly, says Kidron, Oramed’s insulin capsule could slow the progression of Type 2 diabetes, which has three classic phases.

The first phase can be addressed through diet and exercise, while the next phase requires oral medications that boost the body’s own insulin production. In the third phase, when the insulin-producing pancreas cannot continue producing the hormone, a patient becomes insulin-dependent.

“We wanted to do more than just replace injections — we wanted to provide an alternative oral medication as an earlier treatment that can extend the second phase and prevent patients from becoming insulin dependent,” says Kidron. “That’s the revolution.”

Nadav Kidron, CEO of Oramed Pharmaceuticals
Nadav Kidron, CEO of Oramed Pharmaceuticals

By offering a better solution in the second phase of the disease, Oramed could assure that people with Type 2 diabetes avoid further complications of the disease, while benefiting from a less painful, more convenient and more affordable treatment.

Other diabetes meds in the pipeline

Because Type 2 diabetes often results from excess body weight, Oramed is also developing an oral capsule containing the hormone exenatide, which helps balance blood sugar levels and controls appetite. Exenatide can be given by injection but it tends to make people nauseous. The oral preparation would reduce that side effect and open it up to a much larger market.

“This is a very potent drug in the world of diabetes. We are now doing trials at Hadassah, and probably toward the end of the first quarter of 2013 we should have results,” says Kidron. “If it’s successful, we will then file for FDA approval.”

Oramed has a third product in the pipeline that combines oral insulin and oral exenatide. Preliminary results of this therapy were presented at the meeting of the American Diabetes Association last June, demonstrating a greater positive effect when the two products were given in tandem.

“We saw that one plus one equals three when people take these together,” says Kidron, “and giving them together is better than giving them separately. So it’s another breakthrough not just in delivery but in combining these products.” Human trials have yet to begin but results in animal models are promising.

Though the company employs just 11 people, Oramed is backed by a scientific advisory board that includes top diabetes researchers. It includes, among others, Nobel Prize laureate Dr. Avram Hershko; Dr. Michael Berelowitz, former senior vice president of Pfizer; Gerald Ostrov, former CEO of Bausch & Lomb and former senior executive of Johnson & Johnson; and Prof. Derek LeRoith, chief of endocrinology, diabetes and bone disease at the Mount Sinai School of Medicine in New York.

*Photo via Shutterstock

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About Abigail Klein Leichman

Abigail Klein Leichman is a writer and associate editor at ISRAEL21c. Prior to moving to Israel in 2007, she was a specialty writer and copy editor at a daily newspaper in New Jersey and has freelanced for a variety of newspapers and periodicals since 1984.
  • http://www.facebook.com/jae91254 Joyce Edwards

    This all sounds very promising!!

  • http://www.facebook.com/profile.php?id=774843641 Ann Gardner

    Oh YEA,  May it become available in Canada in the next five years!   Currently on  Novo Rapid,  NPH, and Liraglutide,  successfully keeping within acceptable limits..  but would love to throw out these pens and switch to more pills.   Arthritis makes  injecting  difficult,  as does failing vision in selecting the proper doses to be taken!

    The next generation of  diabetics will have it so much easier.  

    • Encycloman

      Ann, I am finally on insulin (one slow acting injection a day) after 16 years of not having to do that. There are a TON of good, safe supplements and minerals that could make your reliance on the three you currently take. And would help your levels not swing as much. There are some clinics available in the US (Whitaker Wellness Center, Dr. Jonathan Wright, Dr. Mercola – http://www.mercola.com, and http://www.raysahelian.com/diabetes.html)

  • hubscher

    How do I find out about USA clinical trials?

  • 201331077

    I Love the descovery, children as well as adults. I know you are Gods choosen People and all things are possible thru Him !!!!!!!!  Who might be doing a study on Chrons?

  • http://twitter.com/LeonardSadinsky Leonard Sadinsky

    Great hope for oral insulins. Whhat an advance this would be.

  • http://twitter.com/LeonardSadinsky Leonard Sadinsky

    Great article on the advance of oral insulins. It would be a major breakthrough in Diabetes.

  • 9102857507

     It seems that most other ailments in this world are curable – but diabetes is among those that are not!!  How comforting it is to see that efforts are being made to bring relief to T2 sufferers worldwide.  Keep up the good work, and may Hashem bless you richly.

  • Rob Woolfson

    I am pretty sure this makes no sense “A capsule taken by mouth would be more convenient and also more natural, as it would mimic insulin’s normal route in the body.” The pancreas (actually the Beta cells in the Islets of Langerhans) produces the hormone and releases it through the endocrine system. I do not see how taking protein orally and it going through the digestive system mimics insulin’s route through the body. Also presumable it is significantly slower than injecting. So aside from helping those who are physically unable to inject, I fail to see how this is a big advice. Surely the way forward is implants, either biological or electronic, like artificial pancreases that actually mimic the behaviour of the body with regard to insulin and sugar levels.

  • Mark Belas

    Let us pray that HASHEM leads the scientists/researchers to find the cure for Diabetes.
    That the cure might be found in Israel makes it that much sweeter.