By United with Israel Staff
People who suffer from diabetes frequently require insulin shots, causing pain, inconvenience, and visible scars that do not heal. To address this pressing healthcare issue, a company based in Israel developed the first oral insulin capsule, called ORMD-0801, providing diabetes treatment without the need for shots.
The pill passed previous rounds of testing with impressive results, placing it on the fast-track for commercial availability, Oramed announced last spring.
Nearly half a billion people worldwide suffer from diabetes.
On Monday, ORMD-0801 started final stage tests, marking the near culmination of close to a decade and a half of development.
If the U.S. Food and Drug Administration (FDA) ultimately approves the drug, type 2 diabetics will be able to start taking insulin pills in a little over three years, with type 1 diabetics permitted to use it after further testing.
In its previous round of testing, Oramed completed placebo-controlled, double-blind, randomized 90-day dose-ranging tests. Fifty-seven US-based patients suffering from type 2 diabetes with inadequate glycemic control completed the 12-week trial.
“Treatment with ORMD-0801 at all doses demonstrated an excellent safety profile, with no serious drug-related adverse events and no increased frequency of hypoglycemic episodes or weight gain compared to placebo,” said a company statement.
Oramed’s Chief Executive Officer, Nadav Kidron, said, “We believe the strong efficacy shown while treating patients at a lower dose further demonstrates ORMD-0801’s potential as a safe, non-invasive, and effective oral insulin solution for the millions of people suffering from diabetes worldwide.”
Joel M. Neutel, MD, the Principal Investigator of the ORMD-0801 Phase 2b trial, commented, “I believe the data demonstrated in this second cohort further validates the clinical potential of Oramed’s oral insulin to have a highly beneficial impact on the treatment of diabetes the world over.”
Oramed already developed a novel Protein Oral Delivery technology based on more than 30 years of research by scientists at Jerusalem’s Hadassah Medical Center. This innovation segued well into the oral insulin capsule.
“Since insulin was first discovered, it has been impossible to deliver it orally, because of degradation and factors affecting absorbance; since insulin is a protein, the body breaks it down when ingested,” Forbes reported in the spring. “The company uses enteric coating and special protection which allows the insulin to stay intact through the GI tract and reach the intestinal wall. Via special absorption enhancers, the insulin can pass through this wall and into the liver, where it starts working. Importantly, it mimics the natural path of insulin in the body, by heading to the liver first.”
The creation of this insulin capsule could not have come at a more opportune time, with the Washington Post reporting last year that the rising costs of insulin has forced some diabetics to ration their treatment, putting their lives at risk.
Kidron said he is “confident that the cost of the pill will be significantly lower (by tens of percent) than the cost of insulin injections,” Forbes reported.
While an Indian company called Biocon is also working on an oral insulin formulation, its product has yet to begin advanced FDA trials.
