Oramed Announces Positive Phase 2a Clinical Trial Results For Oral Insulin Capsule

Oramed Pharmaceuticals Inc. announced in a press release that the Phase 2a clinical trial for its oral insulin capsule showed positive results. Oral insulin (ORMD-0801) treats type 2 diabetes. The trial’s design met the protocol requirements for the Food and Drug Administration’s (FDA) Investigational New Drug (IND) program.

The Phase 2a study sought to evaluate the pharmacodynamics and the safety of the drug. In early stage diabetes, ORMD-0801 slows disease progression by providing insulin and rest for the pancreas. Oramed plans to proceed to further trials.

Type 2 Diabetes

Diabetes is a blood glucose or blood sugar disorder, also called hyperglycemia. Type 2 diabetes is the most prevalent type of diabetes. The body does not make enough insulin or uses insulin inefficiently. Young people can develop the disease, but it is most often found in older adults. Without proper amounts of insulin, the body cannot break down sugar for energy and organs like the kidneys, eyes, and heart can be damaged by high sugar levels. In early stages of the disease, the pancreas attempts to make extra insulin, but this effort is not enough and the pancreas is worse for the wear.

ORMD-0801 Oral Insulin

ORMD-0801 is an oral capsule. It works in the early stages providing insulin, giving the pancreas a rest. The capsule enhances patient usage as the digestible form increases patient compliance. Additionally, the drug’s composition allows it to pass through the liver before passing into the bloodstream. This delivery method mimic’s the natural production of insulin, giving the drug an advantage.

The ORMD-0801 Phase 2a Clinical Trial

In the ORMD-0801 Phase 2a Clinical Trial, 30 patients participated as in-patients for a one week time period. The study included primary and secondary endpoints, or clinically relevant progress markers. The primary endpoint was for tolerability and safety. The secondary endpoints measured the pharmacodynamic effects on mean night time glucose, the pharmacokinetics on AUC, Cmax, Tmax, T½, and the changes from baseline in FBG, morning fasting insulin, C-peptide. Endpoints were evaluated against a placebo. Oramed CEO Nadav Kidron said, “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.”

About Oramed Pharmaceuticals

Oramed Pharmaceuticals specializes in oral drug delivery systems for vaccines and drugs. The company plans a multi-center Phase 2b study for type 2 diabetes and plans to study it for type 1 diabetes as well.

Source:

http://www.oramed.com/ufiles/Oramed%20-%20PR%20Phase%202a%20results.pdf/