Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) began screening patients for its two Phase 3 trials evaluating ORMD-0801 for the treatment of Type 2 diabetes.
The trials will enroll a total of 1,125 Type 2 diabetes patients who have inadequate glycemic control. Patients will be treated over a period of six-to-12 months, with efficacy data expected after all patients have completed the first six-month treatment period.
The first of the two Phase 3 trials, ORA-D-013-1, is recruiting 675 patients who are currently on up to three oral glucose-lowering agents. The study’s primary endpoint is the efficacy of ORMD-0801 in improving glycemic control as assessed by A1c, compared with placebo. The secondary endpoint is the change from baseline in fasting plasma glucose at 26 weeks.
In a statement, Oramed’s CEO, Nadav Kidron, said, “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-approved] Phase 3 oral insulin trial. Oramed is proud to lead the field in reaching this very significant diabetes treatment milestone.”