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.
"This is our most important study to date," says Oramed CEO Nadav Kidron. "A year from now we will better know the potential of our drug to control and maintain blood glucose levels and will have further proof of the longer-term benefits of taking an oral pill versus an injection."
Delivering insulin in a pill form would undoubtedly revolutionize treatment for millions of diabetics. As well as removing the burden of injections and constant blood monitoring, oral administration delivers insulin into the body in a way that needles cannot replicate.
"Not only does oral insulin offer a more convenient alternative to needles, a therapy many patients are reluctant to begin," explains Kidron, "but it also provides a more efficient and safer platform for delivering insulin by mimicking the body's natural process of insulin going directly to the liver rather than via the bloodstream."
This final Phase 2 trial was advised by the FDA after meetings with Oramed in late 2017. If successful this study should lead to final phase trials in 2019/20, ahead of registration that will ultimately bring the treatment to the market. Several companies are currently racing through development of different formulations of oral insulin so the next few years will certainly prove exciting for those suffering from diabetes and looking forward to new treatments.
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