Oramed, which develops oral drug delivery solutions to replace those drugs and vaccines currently delivered via injection, said its flagship product, ORMD-0801, an oral insulin capsule for the treatment of type 2 diabetes, met safety and other endpoint expectations in a Phase 2a trial. The drug trial, which involved 30 patients with type 2 diabetes, was conducted under an Investigational New Drug application with the Food and Drug Administration.
Current research has shown insulin administered in the earlier stages of type 2 diabetes gives the pancreas a needed break so that it can continue producing some insulin on its own. Yet many patients do not want to introduce injections into their daily routine, especially when they are experiencing only mild symptoms; for this reason, patients generally wait to start injectable insulin treatment until the late stages of type 2 diabetes, at the point when their pancreas has ceased insulin production entirely. This disease management practice leaves a person insulin-dependent for life.
By creating an orally-ingestible insulin capsule, referred to as ORMD-0801, Oramed seeks to provide the body with supplemental insulin at the early stages of type 2 diabetes and so lift some of the burden from the pancreas, which would result in curbing disease progression. Oral insulin, as opposed to injectable insulin, more naturally mimics the insulin produced by the body. Because it is metabolized in the liver, fewer or no hypoglycemic episodes occur. Injectable insulin, on the other hand, may circulate at dangerously high doses as a result of being delivered directly into the circulatory system, sometimes causing fatal side effects. It is also presumed patients in the earliest stages of type 2 diabetes would be more willing to adopt an oral drug routine, as opposed to begin taking shots, and thus preserve their quality of life and some independence.
Those who participated in the mid-stage trial received ORMD-0801 in an in-patient setting for one week. Nadav Kidron, Oramed's CEO, said the company is planning a Phase 2b study later in 2014 and will also move forward with Phase 2a testing of ORMD-0801 on type 1 diabetes. Formerly known as juvenile diabetes, type 1 diabetes affects both children and adult populations. The disease causes an autoimmune reaction that destroys the body's insulin-producing cells in the pancreas and so insulin must be provided from an external source. Oramed proposes to introduce ORMD-0801 as a complementary treatment to the standard insulin injections. The hope is such treatment will allow for fewer daily injections while also lowering the frequency of blood glucose fluctuations.
"We are extremely pleased with the results which give a solid validation for Oramed's platform technology in general and our oral insulin program in particular," Kidron said.