Press release
Oramed Reaches 50% Enrollment in its Second Phase 3 Oral Insulin Trial
- ORA-D-013-2 is the second of two Phase 3 trials under FDA protocol - ORA-D-013-1, the larger of the two trials, completed enrollment with top line data
About this update from Oramed Pharmaceuticals Inc.
[{"type":"text","content":"- ORA-D-013-2 is the second of two Phase 3 trials under FDA protocol \n- ORA-D-013-1, the larger of the two trials, completed enrollment with top line data expected January 2023\nNEW YORK, July 26, 2022 /PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced today that it has enrolled and randomized over 50% of the planned 450 patients for its international multicenter Phase 3 ORA-D-013-2 trial of its oral insulin capsule, ORMD-0801, for the treatment of type 2 diabetes (T2D).\nORA-D-013-2 is the second of Oramed's two Phase 3 trials being conducted under U.S. Food and Drug Administration (FDA) Investigational New Drug Application (IND) to treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months.\n\"We are very pleased as we head into the latter half of enrollment for our ORA-D-013-2 trial, especially after having just completed 100% enrollment in our larger ORA-013-1 trial which randomized a total of 710 patients. Together, these trials are the world's first Phase 3 oral insulin trials conducted under a U.S. FDA IND,\" said Oramed's Chief Executive Officer, Nadav Kidron.\nAbout the TrialThe ORA-D-013-2 trial is recruiting 450 T2D patients with inadequate glycemic control who are managing their condition with either diet alone or with diet and metformin monotherapy. The double-blind trial will randomize patients 1:1 into two cohorts dosed with 8 mg of ORMD-0801 at night or placebo at night. The primary endpoint of the trial is to compare the efficacy of ORMD-0801 to placebo in improving glycemic control as assessed by A1c over a 26-week treatment period, with a secondary endpoint of comparing ORMD-0801 to placebo in maintaining glycemic control over a 52-week treatment period.\nAbout Oramed PharmaceuticalsOramed 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 is being evaluated in two pivotal Phase 3 studie...