ISRAEL: Clinical trials hold promise for world's first insulin pill

Record ID: 398336

  • Title: ISRAEL: Clinical trials hold promise for world's first insulin pill
  • Date: 30th March 2014
  • Summary: EIN KAREM, ISRAEL (RECENT) (REUTERS) VARIOUS OF KIDRON AND LAB ASSISTANT WORKING IN LABORATORY (SOUNDBITE) (English) MIRIAM KIDRON, CHIEF SCIENTIST AT ORAMED PHARMACEUTICALS, SAYING: "When we give insulin orally, first pass goes through the liver because it goes from the intestine to the liver. Unlike the injection which first passes through the circulation - and this is
  • Embargoed: 14th April 2014 13:00
  • Keywords:
  • Location: Israel
  • Country: Israel
  • Topics: Health
  • Reuters ID: LVA5DFXQXUJIZ1Q68MAKB8F7HLO5
  • Story Text: An Israeli pharmaceutical company, Oramed, is developing an insulin pill that it says could relieve thousands of diabetics from daily injections. If clinical trials prove successful, it will be the first insulin pill ever developed.
    The concept of oral insulin has been discussed since the 1930s, but making it a reality has been extremely difficult because insulin cannot survive the destructive enzymes in the digestive system.
    Oramed believes that it has now found a solution to allow enough insulin to survive the onslaught of digestive juices to be effective.
    The capsule is covered in a unique coating which protects it from degrading during its journey down the gastrointestinal tract. This coating is PH sensitive and only degrades upon exposure to the lower level of acidity in the small intestine, allowing the insulin to be released directly into the liver.
    Dr. Miriam Kidron, Chief Scientist at Oramed, says that unlike injected insulin, the ingested insulin passes first into the liver, which regulates the secretion of insulin into the bloodstream.
    "When we give insulin orally, first pass goes through the liver because it goes from the intestine to the liver. Unlike the injection which first passes through the circulation - and this is the main big difference between giving it orally or giving it as an injection. And that's why it's very important to try and to have the success in giving insulin orally," Kidron said.
    Kidron says its insulin capsule met all primary and secondary endpoints in a Phase IIa (Two A) clinical trial. It now plans to launch a larger mid-stage study.
    Diabetes is an autoimmune disease in which the pancreas fails to produce insulin, a hormone that enables glucose in the blood to enter cells to produce energy. In most cases, if not treated with daily injections of insulin, it can be fatal.
    The pill would not completely eliminate the need for injections, but for Type 2 diabetics - in whom the disease usually develops in adulthood through inactivity, obesity or genetics - it could delay the shift to needles by many years. Injectable insulin is usually administered during the late stages of Type 2 diabetes, when the pancreas can no longer produce insulin. Type 1 diabetes is far less common and
    usually develops in children. It is believed to be caused either by genetic susceptibility or environmental factors.
    Harold Jacob, Director of Endoscopy at Hadassah hospital and a board member of Oramed, says oral insulin could make it easier for diabetics to start early treatment, slow progression of the disease and delay the need for injections.
    "The pill is a regular pill that of which many pills are swallowed every day as you know throughout the world. This is the same type of preparation, it's a simple pill which is swallowed, goes into the small intestine, to the duodenum and is absorbed and is absorbed there. Very easily taken, very easily tolerated thus far clinical trials have shown that it's very safe and we're hopeful that it will also have a very important therapeutic role in the treatment of diabetes," Jacob said.
    At least 90 percent of the more than 382 million diabetes sufferers world-wide are in the type 2 category, according to the International Diabetes Foundation, which expects the number of diabetes patients to near 600 million by 2035.
    Danish company Novo Nordisk is also trying to develop its own insulin capsule, but has yet to start Phase II of testing.
    The global cost of diabetes is about $500 billion USD a year and an oral treatment could bring a sizeable reduction in costs.
    At Hadassah Hospital half a dozen volunteers are taking part in the trials. They are given the pills, and then their blood samples are taken every 15 minutes to monitor the drug's effect on their sugar levels.
    Yaniv Cohen, 29, says he was diagnosed with Type 1 diabetes 12 years ago, and has since been relying on a regimen of injections, which can be burdensome.
    "I take three or four shots a day, and with this product you just need to swallow a pill and it takes your blood sugar down. I think one of the reasons I came here, I wanted to try it, instead of taking the shots," Cohen said.
    Oramed will 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 commercialisation.
    The pill would not completely eliminate the need for injections, but for Type 2 diabetics it could delay the shift to needles by many years. Injectable insulin is usually administered during the late stages of Type 2 diabetes, when the pancreas can no longer produce insulin.
    .
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