Israel-based Oramed announced that it has sent an application to the Food and Drug Administration for permission to enter Phase 2 trials of its oral insulin product. The company has been working on developing a means of delivering insulin orally, which would allow people with diabetes to avoid having to inject themselves with the hormone.
If the FDA gives the go ahead, Oramed will conduct a 12-month trial and 10 different locations across the United States. The test will involve 147 type 2 diabetes patients who will be divided into three groups: one receiving placebo and two who will take the Oramed drug at different dosage levels.
Developing an insulin that can be taken orally has been a long-sought goal among pharmaceutical companies. Because of the hormone’s delicate molecular structure, the problem has been to find a way to shield it from the corrosive effects of the digestive system’s highly acidic environment and deliver it intact to the bloodstream.
Although type 2 diabetes patients who use insulin benefit from extremely thin needle technology that has taken much of the sting and pain out of injections, an oral form of the hormone would remove all pain from the dosing process as well as eliminate the cost of needles and syringes.
The company also announced that it is ready to begin testing its oral exenatide product on type 2 patients, with results expected by the end of the first quarter of this year. Exenatide, a GLP-1 analog, is the basis of the popular and widely used brand-name drugs Byetta and Bydureon (Amylin Pharmaceuticals). Both drugs are taken by injection; Byetta twice daily and Bydureon once weekly.
Oramed is also experimenting with a therapy that combines oral insulin and oral exenatide. The company presented preliminary results of the therapy at the scientific sessions of the American Diabetes Association last June, saying the two drugs provided greater benefits working together rather than by themselves.