Oramed Pharmaceuticals Inc., a developer of alternative drug delivery systems, recently reported results for its completed Phase IIb non-FDA clinical trial of its flagship oral insulin capsule, ORMD-0801.

The randomized, double-blind, placebo-controlled, multi-centered study conducted in South Africa evaluated responses of 29 type 2 diabetes patients to ORMD-0801. Insulin-loaded or placebo capsules were administered to patients who were closely monitored throughout the 6-week study period. Safety, tolerability, and efficacy parameters of Oramed’s oral insulin were assessed.

ORMD-0801 was found to be well-tolerated and exhibited a positive safety profile. No cumulative adverse effects were reported throughout this first study of extended exposure to ORMD-0801. In addition, the percentage of subjects demonstrating clinically relevant reductions in insulin, c-peptide, fasting blood glucose, and Hb1Ac levels was always higher in the ORMD-0801 cohort, when compared to the placebo. Moreover, mean decreases in insulin and CRP levels were found to be statistically significant following the 6-week, once-daily ORMD-0801 treatment period. These findings suggest that ORMD-0801 attenuates insulin oversecretion, reprieving beta cells from their heightened activity. The reported results substantiate the safety and tolerability of ORMD-0801 and demonstrate that oral insulin has a relevant clinical impact at the tested dose. The data collected from this trial will help to further the development of ORMD-0801 in future, pivotal trials.

“The results of this trial once again underscore the safety of Oramed's oral insulin preparation,” said Harold Jacob, MD, a member of the Oramed Board of Directors. “These results show a positive trend of efficacy for the tested oral insulin preparation.”

“This study, as well as data from our earlier studies, suggests that Oramed’s technology is an effective and well-tolerated delivery platform that will potentially make a significant clinical impact on diabetes management. We are proceeding with confidence toward IND approval in the US,” added Nadav Kidron, Chief Executive Officer of Oramed Pharmaceuticals.