Oramed Initiates Second Phase 3 Oral Insulin Study

Oramed Pharmaceuticals has screened the first patients in its ORA-D-013-2 study, the second of two concurrent Phase 3 studies of its oral insulin capsule, ORMD-0801, for the treatment of type 2 diabetes (T2D).

The studies are taking place under U.S. Food and Drug Administration (FDA) approved protocols to treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months. The double-blinded, placebo-controlled, multi-center randomized studies will recruit a total of 1,125 patients to evaluate the efficacy and safety of ORMD-0801. Efficacy data for the studies will become available after all patients have completed the first 6-month treatment period.

"With both concurrent Phase 3 studies now enrolling, we have achieved another world-first milestone, as the only company to conduct two Phase 3 oral insulin studies under an FDA protocol. While ORA-D-013-1 will help us evaluate our oral insulin capsule in patients who are already on two or three glucose-lowering medications, ORA-D-013-2 will help us assess our oral insulin capsule in patients who are on diet control alone or on diet and metformin monotherapy. Evaluating ORMD-0801 in these diverse population groups is expected to yield compelling results for use cases upon potential approval," said Oramed CEO Nadav Kidron.

The ORA-D-013-2 study is recruiting 450 T2D patients with inadequate glycemic control who are managing their condition with either diet alone or with diet and metformin monotherapy. Patients will be recruited through 28 sites in the U.S. and 25 sites in Western Europe and Israel. The double-blind study will randomize patients 1:1 into two cohorts dosed with 8 mg of ORMD-0801 at night and placebo at night. The primary endpoint of the study is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1c over a 26-week treatment period, with a secondary endpoint of comparing ORMD-0801 to placebo in maintaining glycemic control over a 52-week treatment period.