Millions of diabetic patients around the world are about to get rid of painful injection insulins, soon. Israeli pharmaceutical company Oramed Pharmaceuticals, which also has its office and laboratories in the United States has been successfully advancing completing trial of the oral insulin, which would be available in the market by the end of 2022.
Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced that it has enrolled and randomized over 50 percent 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).
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. 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.
“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.
ORA-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.
The 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.
Oramed 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 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 Administration. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule, ORMD-0901.
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