Oral Insulin Capsule
Injectable insulins are generally administered during the late stages of Type 2 diabetes mellitus (T2DM), when the pancreas can no longer produce insulin - leaving the patient insulin-dependent for life. Curbing disease progression is thus paramount to increasing patient quality of life and independence.
Current research has shown that administration of insulin at earlier stages of T2DM has positive effects, and is now beginning to be included in standard treatment regimens. While the benefits can be significant, some patients are still hesitant to introduce injections into their daily routine, especially when earlier stages of the disease tend to induce mild symptoms, easily disregarded by patients.
Oramed's oral insulin is indicated for the earlystages of T2DM, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite.
Orally administered insulin has the potential benefit of enhanced patient compliance at this crucial stage. Moreover, oral insulin has the added benefit of mimicking insulin's natural location and gradients in the body by first passing through the liver before entering the bloodstream.
The insulin undergoes first-pass metabolism in the liver yielding physiologically relevant insulin concentrations for systemic circulation. By such means fewer or no hypoglycemic episodes occur. This stands in sharp contrast tothe sometimes fatal side effects of injectable insulin, wherein the insulin may be circulating at dangerously high doses as a result of being delivered directly into the systemic circulation, thus bypassing the body's natural metabolic mechanisms.
ORMD-0801: A Note on Type 1 Diabetes Mellitus (T1DM)
Today, T1DM, formerly known as juvenile diabetes, affects both young and adult populations. In this form of the disease, an autoimmune reaction destroys the body's insulin-producing cells in the pancreas. In this form of the disease, insulin must be provided from an external source.
Oramed proposes to introduce ORMD-0801 treatment as a complementary agent to insulin injections in the treatment of T1DM. Such a treatment regimen will allow for fewer daily injections and has been shown to lower the frequency of blood glucose fluctuations in cases of unstable T1DM.
ORMD-0801: Current Status
FDA-approved Phase II Trial in the U.S.
A new IND (Investigational New Drug) application was filed with the United States Food and Drug Administration (FDA) on April 12, 2013. This filing was in response to FDA feedback on Oramed's initial IND (filed December 31, 2012) for a multi-centered Phase 2 trial on type 2 diabetics in the US; the FDA requested Oramed complete a sub-study prior to beginning the larger-scale Phase 2 trial. The sub-study and phase 2 trial will begin pending FDA clearance.
Population and Location: 147 T2DM patients in multiple treatment centers across the U.S.
ORMD-0801: Clinical Trial History
After traveling through the gastrointestinal tract in its encapsulated form, the insulin is released in the small intestine. From there, it is ferried to the liver via the portal vein.