NEW YORK—Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has initiated a food effect study in the U.S. for its oral insulin capsule ORMD-0801.
The food effect study is a single blind, five period, randomized, placebo-controlled crossover study to evaluate the pharmacokinetics and pharmacodynamics of ORMD-0801 taken at different times in relation to meals in both healthy volunteers and subjects with type 1 diabetes. Up to 48 subjects will be enrolled, including 24 healthy volunteers and 24 subjects with type 1 diabetes.
Oramed’s Protein Oral Delivery (POD) technology is based on over 30 years of research by top scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration.
As Oramed points out on its website, orally administered insulin should enhance patient compliance. “In addition, intestinally absorbed-oral insulin actually mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.”
“Following a successful Phase 2 study which demonstrated ORMD-0801’s use before mealtime in type 1 diabetics, this food effect study will further explore optimal timing of ORMD-0801 dosing relative to food intake,” stated Nadav Kidron, CEO of Oramed.
“Oramed’s oral insulin capsule is anticipated for use as a complementary agent to insulin injections in the treatment of T1DM,” according to Oramed’s website. “This treatment regimen should allow for fewer daily injections and a lower frequency of blood glucose fluctuations in cases of unstable and brittle T1DM [Type 1 diabetes management]. ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications.”
In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901). “Glucagon-like peptide-1 (GLP-1) is an incretin hormone that stimulates the secretion of insulin from the pancreas. Exenatide, a GLP-1 analog, is currently marketed in injectable form only, and is indicated for treatment of type 2 diabetes,” notes the website. “Exenatide induces insulin release at increased glucose levels and causes a feeling of satiety, which results in reduced food intake and weight loss. Oramed’s oral GLP-1 capsule based on the company’s POD technology could significantly increase compliance and become a valuable tool in the treatment of diabetes.”
The website also notes that “The combination therapy of insulin and GLP-1 analogs have shown to be highly effective at achieving optimal blood sugar control without an increased risk for hypoglycemia. In addition, patients on a combination-therapy regimen have been shown to lose weight during treatment. Both insulin and GLP-1 analogs are currently only available via injection. Oramed is pursuing an oral combination therapy for the management of T2DM, by combining the advantages of ORMD-0801 and ORMD-0901.”