Oramed Pharmaceuticals, Inc., a developer of alternative drug delivery systems, reported results for the recently completed Phase 2b 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 over secretion, 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.
Harold Jacob, M.D., a member of the Oramed Board of Directors, said, “The results of this trial once again underscore the safety of Oramed’s oral insulin preparation. These results show a positive trend of efficacy for the tested oral insulin preparation.” Nadav Kidron, Chief Executive Officer of Oramed Pharmaceuticals, added, “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 United States.”
Oramed Pharmaceuticals Inc, May 2010