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May 4, 2022

Oramed concludes patient enrolment in Phase III oral insulin trial

Assessing the efficacy of ORMD-0801 versus placebo in boosting glycemic control is the primary endpoint of the trial.

Oramed Pharmaceuticals has concluded subject enrolment in Phase III ORA-D-013-1 clinical trial of its oral insulin capsule, ORMD-0801, to treat patients with type 2 diabetes (T2D).

The trial enrolled 710 patients as against its target of 675 subjects. 

A lead candidate of the company, ORMD-0801 is being analysed in two Phase III trials and can become the first commercial oral insulin capsule to treat diabetes. 

ORA-D-013-1 is being carried out under protocols approved by the US Food and Drug Administration (FDA) for treating patients with T2D, who have insufficient glycemic control for six to 12 months. 

The subjects enrolled in the trial, through 96 study sites in the US, are presently receiving two or three oral glucose-lowering agents.

Assessing the efficacy of ORMD-0801 versus placebo in boosting glycemic control as evaluated by A1c is the trial’s primary endpoint.

The secondary endpoint is evaluating the change in fasting plasma glucose from baseline at 26 weeks. 

The company expects efficacy results from the trial on all trial subjects completing the initial six-month treatment period while topline trial findings are anticipated in January next year.

Oramed CEO Nadav Kidron said: “We are thrilled to announce that the world’s first Phase III oral insulin study, conducted under an FDA protocol, has achieved a significant milestone with the completion of enrolment. 

“We are very excited about the prospect of an oral insulin option for people living with diabetes. 

“Being delivered orally, oral insulin mimics endogenous insulin regulation before reaching the bloodstream, providing better blood glucose control and potentially reducing risks and complications associated with injectable insulin, including weight gain and hypoglycemia, while also being easier to administer.”

In March this year, the company completed patient enrolment in a Phase II trial of ORMD-0801 for treating non-alcoholic steatohepatitis.

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