Oramed Releases Phase 2b Non-FDA Oral Insulin Capsule Trial Results

Oramed Pharmaceuticals said that the randomised, 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.

Reportedly, ORMD-0801 was found to be well tolerated and exhibited a positive safety profile. No cumulative adverse effects were reported throughout this 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.

Additionally, mean decreases in insulin and CRP levels were found to be 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 clinical impact at the tested dose. The data collected from this trial is expected to help to further the development of ORMD-0801 in future, pivotal trials.

Harold Jacob, a member of the board of directors of Oramed Pharmaceuticals, 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, CEO of Oramed Pharmaceuticals, said: “This study, as well as data from our earlier studies, suggests that Oramed’s technology is an effective and well-tolerated delivery platform that is expected to potentially make a clinical impact on diabetes management. We are proceeding towards IND approval in the US.”