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

Loading...
Loading...

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.

Loading...
Loading...
Posted In: BiotechHealth CareSmall CapGeneralPatient Enrollment Update
We simplify the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!

Loading...