For decades researchers have worked to find a way to orally administer insulin effectively to patients with diabetes. Now this game-changing treatment is one step closer to reality, with pharmaceutical company Oramed embarking on a final Phase 2b human clinical trial to prove the efficacy of its oral insulin before moving to the final stages of trials and registrations that could bring the treatment to market within a few short years.
Oral insulin has long been considered the holy grail of diabetes treatment with many scientists trying, and failing, to produce an effective drug. The big challenge is that the acidity of the stomach degrades the protein before it can pass through into the intestine for absorption.
The big development from Oramed was in creating not only a pH sensitive capsule coating that protects the drug until it reaches the small intestine, but to also enhance the ability of the insulin to permeate the intestinal membrane and better cross into the bloodstream. This oral insulin formation has successfully moved through Phase 1 safety trials and several Phase 2 trials, demonstrating a statistically significant blood glucose lowering efficacy. This new trial is set to examine the drug’s impact over 90 days, after earlier trials only studied the efficacy over 28 days.