Oramed's ORMD-0801 hits goals of Phase II trial in NASH

Israeli diabetes specialist Oramed Pharmaceuticals’ (Nasdaq/TASE: ORMP) shares edged up 3% to $8.46 pre-market today, as it announced positive Phase II 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 (T2D) patients with non-alcoholic steatohepatitis (NASH).

The 12-week trial enrolled 32 patients (with 30 patients completing) and demonstrated that ORMD-0801 was safe and well tolerated at 8mg 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.