Press release
Oramed Reaches 50% Enrollment in Phase 3 Oral Insulin Study
First and Largest of two concurrent Phase 3 trials on track to complete randomization by Q4 2021 NEW YORK, June 8, 2021 /PRNewswire/ -- Oramed Pharmaceuticals
About this update from Oramed Pharmaceuticals Inc.
[{"type":"text","content":"First and Largest of two concurrent Phase 3 trials on track to complete randomization by Q4 2021\n\n\nNEW YORK, June 8, 2021 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has enrolled and randomized over 50% of the 675 patients planned for its Phase 3 ORA-D-013-1 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D). \nORA-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. The concurrent study, ORA-D-013-2, commenced enrollment in March for a planned 450 patients. Efficacy data for ORA-D-013-1 will become available after all patients have completed the first 6-month treatment period.\n\"As we continue on pace with randomization in the world's first Phase 3 oral insulin study conducted under an FDA approved protocol, we anticipate announcing topline results in 2022,\" said Oramed CEO Nadav Kidron.\nAbout the Study\nORA-D-013-1 is recruiting 675 patients who are currently on 2 or 3 oral glucose-lowering agents through 75 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.\nThe ORA-D-013-1 trial is a double blind, double dummy study randomizing patients 1:1:1 for: 8 mg ORMD-0801 once-daily at night and placebo 45 minutes before breakfast; or 8 mg ORMD-0801 twice-daily at night and 45 minutes before breakfast; or placebo twice daily at night and 45 minutes before breakfast. \nAbout Oramed Pharmaceuticals\nOramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of...