Making insulin delivery in capsule form a reality

The ability to correctly self-administer doses of insulin is crucial to the long-term health of diabetics. For years, the only method patients had to deliver insulin to their bodies was  by injection. But, years of research by Oramed’s highly respected team of scientists discovered a technology at the Hadassah University Hospital that has the potential to change all of that.

Up until now, the idea of insulin pills or capsules was inconceivable due to the fact that insulin, which is a protein, breaks down in the digestive system. However, Oramed’s patented technology overcame the problem of digestion as well as permeability to the intestine. This has been a major hurdle that has inhibited the development of an orally ingestible insulin for decades. 

The route of the insulin from the swallowed capsule "imitates nature" in that it passes to the liver and then to the bloodstream. Injected insulin goes straight to the bloodstream. 

In August 2008, Oramed successfully completed Phase 2A clinical trials of its oral insulin capsule. This trial was the first to expose patients with type 2 diabetes to ORMD 0801 and its primary goals were to assess the safety, tolerability and pharmcodynamic effects in these patients.  ORMD 0801 was well tolerated by all patients and had a good safety profile; no serious adverse events were encountered throughout the study. In two thirds of the subjects analyzed, statistically significant reductions in glucose as well as C-peptide were observed.

Phase 2B clinical trials are expected to commence in the first quarter of 2009.

Other products in development:

* Insulin suppository