Oramed Pharmaceuticals Inc. announced positive Phase 2 results from its double-blind, fully randomized, placebo-controlled, multicenter trial to assess the safety and efficacy of its oral insulin candidate (ORMD-0801), to reduce liver fat content in Type 2 Diabetes patients with non-alcoholic steatohepatitis. The 12-week trial enrolled 32 patients (with 30 patients completing) and demonstrated that ORMD-0801 was safe and well tolerated at 8 mg twice daily dosing, meeting the primary endpoint of no difference in adverse events for ORMD-0801 compared to placebo. The trial also evaluated the effectiveness of ORMD-0801 in reducing liver fat content over the 12-week treatment period by observing several independent measures.

These measurements included MR PDFF(%) as measured by MRI, Steatosis and Fibrosis as measured by Fibroscan, Lipids and HbA1c. All the measurements showed a consistent clinically meaningful trend in favor of ORMD-0801.