ORMP - Oramed reaches 75% enrollment in Phase 3 oral insulin study

Oramed Pharmaceuticals (NASDAQ:ORMP) has enrolled and randomized over 75% 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). Shares down 3.4% premarket at $18.30. ORA-D-013-1 is the larger of Oramed's two Phase 3 studies being conducted to treat T2D patients who have inadequate glycemic control over a period of 6 to 12 months. 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 concurrent study, ORA-D-013-2, commenced enrollment in March for a planned 450 patients. Topline results are anticipated in in 2022.

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Oramed reaches 75% enrollment in Phase 3 oral insulin study