Oramed Completes Patient Enrollment in Pivotal Phase 3 Oral Insulin Study ORA-D-013-1
· ORMD-0801 positioned to potentially be the first FDA approved oral insulin for the treatment of diabetes
· Completed enrollment of 710 patients for the Phase 3 ORA-D-013-1 study
· Top line data expected in January 2023
NEW YORK, May 3, 2022 – Oramed Pharmaceuticals Inc. (NASDAQ/TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced it has completed patient enrollment for its Phase 3 ORA-D-013-1 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D), surpassing its target of 675 patients with 710 patients enrolled.
ORA-D-013-1 is the larger of Oramed’s two Phase 3 studies being conducted 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. Efficacy data for ORA-D-013-1 will become available after all patients have completed the first 6-month treatment period.
“We are thrilled to announce that the world’s first Phase 3 oral insulin study, conducted under an FDA protocol, has achieved a significant milestone with the completion of enrollment. Following the last patient’s six months of treatment, we anticipate announcing topline results in January 2023,” said Oramed CEO Nadav Kidron. “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. I would like to thank all of the patients, investigators and partners involved in this clinical trial, all with the common goal of bringing forth a breakthrough in diabetes therapy.”
About the Study
The ORA-D-013-1 study initially aimed to enroll 675 patients and has now completed its enrollment oversubscribed with a total of 710 patients. The enrolled patients are currently on 2 or 3 oral glucose-lowering agents through 96 clinical sites throughout the U.S. The primary endpoint of the study is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1c, with a secondary endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. Efficacy data will become available after all patients have completed the first 6-month treatment period. More information can be found here: ORA-D-013-1
