Oramed Pharmaceuticals Inc. (OTCBB: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, presented the results of its recently completed Phase IIb trial. The multicenter, placebo-controlled, randomized, double-blind study conducted in 29 patients with Type II diabetes assessed the safety of ORMD-0801 in patients with Type II diabetes. Results were presented by the company's Chief Scientific Officer, Dr. Miriam Kidron, at the Tenth Annual Meeting of the Diabetes Technology Society, in Bethesda, Maryland.
The poster presentation entitled "Extended exposure to an oral insulin formulation yields decreased insulin secretion in Type II diabetes subjects," described Oramed's first extended exposure study to its oral insulin product (ORMD-0801), where 21 patients were treated with ORMD-0801, self-administered daily for a period of six weeks. In parallel, a group of eight patients received placebo capsules administered under the same treatment regimen. ORMD-0801 proved safe and tolerable, with no reports of serious adverse events throughout the study. In addition, no cumulative effects of extended ORMD-0801 exposure were noted, and only two mild cases of transient hypoglycemia were reported. Treatment efficacy was evaluated via markers quantified from blood samples drawn at the start and end of the study. Daily administration of oral insulin led to a statistically significant decrease in both insulin and C-reactive protein (CRP) levels, in contrast to their elevation among placebo-treated individuals. Moreover, the percentage of subjects demonstrating clinically relevant reductions in insulin, c-peptide, fasting blood glucose (FBG) and Hb1Ac levels was consistently higher in the ORMD-0801 cohort, when compared to its placebo counterpart. This study addressing, for the first time, potential long-term safety concerns from extended ORMD-0801 administrations, demonstrated safety and no serious adverse events were reported.
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