Oramed Initiates Phase 3 Trial of Oral Insulin

Oramed Pharmaceuticals has screened the first patients in its global Phase 3 trials of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D). The patients were screened at U.S. sites participating in Oramed's ORA-D-013-1 trial, one of two Phase 3 trials being conducted in accordance with U.S. Food and Drug Administration approved protocols.

Both Phase 3 trials, ORA-D-013-1 and ORA-D-013-2, will treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months. The double-blinded, placebo-controlled, multi-center randomized trials will recruit a total of 1,125 patients to evaluate the efficacy and safety of ORMD-0801. Efficacy data will become available after all patients have completed the first 6-month treatment period.

"ORMD-0801 is the first oral insulin capsule to achieve the requisite efficacy and safety data enabling us to run the world's first FDA Phase 3 oral insulin trial. Oramed is proud to lead the field in reaching this very significant diabetes treatment milestone," said Oramed CEO Nadav Kidron.

ORA-D-013-1 is recruiting 675 patients who are currently on 1, 2 or 3 oral glucose-lowering agents through 75 clinical sites throughout the U.S. The primary endpoint of the study is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1c, with a secondary endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks.