Oramed completes Ph Ia with oral insulin gel caps

Oramed Pharmaceuticals, an Israeli developer of peptide delivery systems, says that it has successfully completed its exploratory Phase Ia clinical trial with its oral insulin gel capsule. This study was intended to assess both the safety/tolerability and absorption properties of Oramed's proprietary oral insulin delivery technology. The trial examined changes in insulin, glucose and C-peptide plasma concentrations over time in healthy volunteers under several differing oral dosing scenarios. With the exception of the anticipated insulin related hypoglycemic side effects, no significant adverse effects were noted after administration of Oramed's insulin gel capsule.

Based on the pharmacokinetic and pharmacologic outcomes of this early-stage trial, the company and its board of directors have decided to continue the development of the oral insulin product. Additional Phase I bioavailability/pharmacokinetic trials to optimize/finalize the formulation are anticipated to begin later this year. Oramed's goal is for the completion of formal Phase I studies in the USA by mid-2008.