Oramed Accomplishes 50 Percent Enrolment In Late-Stage Oral Insulin Study

Oramed Pharmaceuticals ORMP has enrolled over 50 percent of the planned 450 patients for its international multicenter Phase 3 ORA-D-013-2 trial of oral insulin capsule, ORMD-0801, for the treatment of type 2 diabetes (T2D).

The ORA-D-013-2 clinical study is the second of its two Phase 3 ongoing trials conducted under U.S. Food and Drug Administration (FDA) protocol to treat type 2 diabetes patients who have inadequate glycemic control over a period of 6 to 12 months.

Nadav Kidron, Chief Executive Officer, commented: "We are very pleased as we head into the latter half of enrollment for our ORA-D-013-2 trial, especially after having just completed 100% enrollment in our larger ORA-013-1 trial which randomized a total of 710 patients. Together, these trials are the world's first Phase 3 oral insulin trials conducted under a U.S. FDA IND.”

The primary endpoint of this clinical trial is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1c over a 26-week treatment period.

The company has concluded enrolments in one of the Phase 3 ORA-D-013-1 clinical trial and expecting topline data in the month of January, 2023.

Price Action : Oramed shares are trading around 2 percent at $7.83 on Tuesday at the time of publication.