Oramed Pharmaceuticals has enroled and randomised more than 50% of participants in its second Phase III ORA-D-013-2 international multicentre trial of ORMD-0801, an oral insulin capsule, to treat type 2 diabetes (T2D).
About 450 T2D patients with insufficient glycemic control, handling their condition with diet alone or with diet along with metformin monotherapy are being recruited in the ORA-D-013-2 double-blind trial.
The company’s proprietary lead candidate, ORMD-0801 is being assessed in two pivotal Phase III trials, ORA-D-013-1 and ORA-D-013-2, and can become the first treatment for diabetes by orally delivering insulin at an early stage.
The Phase III ORA-D-013-1 trial completed subject enrolment in May this year and expects to receive top line findings in January next year.
Oramed CEO Nadav Kidron said: “We are very pleased as we head into the latter half of enrolment for our ORA-D-013-2 trial, especially after having just completed 100% enrolment in our larger ORA-013-1 trial which randomised a total of 710 patients.
“Together, these trials are the world’s first Phase 3 oral insulin trials conducted under a US FDA IND.”
The ORA-D-013-2 trial is being conducted under the US Food and Drug Administration (FDA) Investigational New Drug Application (IND).
In this trial, the subjects will be randomised in 1:1 two cohorts and administered with 8mg ORMD-0801 or placebo at night.
The efficacy of ORMD-0801 compared to placebo in enhancing glycemic control as evaluated by A1c over a treatment period of 26 weeks will be the trial’s primary endpoint.
Comparing the ORMD-0801 vs placebo in maintaining the glycemic control for 52-week treatment period will be the secondary endpoint of the trial.