Press release
Oramed Doses Patients Across Multiple Sites in Phase 3 Oral Insulin Study
Randomization of patients in the world's first Phase 3 oral insulin study conducted under FDA approved protocol NEW YORK, Jan. 21, 2021 /PRNewswire/ -- Oramed
About this update from Oramed Pharmaceuticals Inc.
[{"type":"text","content":"Randomization of patients in the world's first Phase 3 oral insulin study conducted under FDA approved protocol\n\n\nNEW YORK, Jan. 21, 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, announced today that randomization of patients in its first Phase 3 study of its oral insulin capsule ORMD-0801 for the treatment of type 2 diabetes (T2D) is under way. The study is being conducted in accordance with U.S. Food and Drug Administration (FDA) approved protocols. \n\"We're excited to be the first company in the world to conduct an FDA approved Phase 3 study for oral insulin,\" said Oramed CEO Nadav Kidron. \"This is an important study and we're pleased that recruitment for the study is proceeding as planned. We look forward to sharing more updates as we progress.\"\nAbout the Study\nORA-D-013-1 is recruiting 675 patients who are currently on two or three 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 is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in New York and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. The Company has completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Ad...