Press release
Oramed Reports Positive Top-Line Results from Phase 2 NASH Trial with its ORMD-0801, Oral Insulin Candidate
Primary endpoint met: ORMD-0801 was safe and well toleratedSecondary endpoint met: ORMD-0801 showed clinically meaningful reduction of liver fat from baseline
About this update from Oramed Pharmaceuticals Inc.
[{"type":"text","content":"Primary endpoint met: ORMD-0801 was safe and well toleratedSecondary endpoint met: ORMD-0801 showed clinically meaningful reduction of liver fat from baseline at 12 weeksStrong evidence for treatment of NASH using Oramed's oral insulinNEW YORK, Sept. 13, 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 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 (\"T2D\") patients with non-alcoholic steatohepatitis (\"NASH\"). \nThe 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.\nThe 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.\n\"These results paint an exciting picture for the potential of our oral insulin candidate to treat patients with both diabetes and NASH, a very serious condition with few treatment options,\" said Oramed's Chief Executive Officer, Nadav Kidron. \"At the same time, we await the top-line data from our Phase 3 trial of oral insulin for T2D, which we expect in January 2023.\"\nAbout the TrialORA-D-N02 is a Phase 2 double-blind, randomized, placebo-controlled, multicenter trial to assess the safety and efficacy of Oramed's oral insulin candidate, ORMD-0801, to reduce liver fat content in T2D patients with NASH. The trial's primary endpoint was to evaluate the safety of oral insulin in patients with NASH and T2D, with a secondary endpoint to assess, non-statistically, ORMD-0801's efficacy in reducing liver fat content in patients with NASH and T2D.\nThe trial recruited 32 patients who were administered either placebo (11 patients) or ORMD-0801 8 mg twice daily ...