Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, announced additional positive data from its Phase 2 double-blind, fully randomized, placebo-controlled, multicenter clinical trial (ORA-D-N02) 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 (“NASH”). The presentation of this new data, including a discussion by key opinion leaders, was featured in a webinar today with a replay available on Oramed‘s website under Events and Presentations.
Professor Yaron Ilan, M.D., Director of the Department of Medicine at the Hebrew University-Hadassah Medical Center, and principal investigator for the clinical trial, commented, “The clinical data scientific results of ORMD-0801 demonstrated positive safety results on key liver-related endpoints such as reduction of fat and fibrosis. In this patient population, the safety of a potential therapy is of paramount importance.”
“We are very encouraged by the detailed data reported today demonstrating a positive safety profile and signs of efficacy for our oral insulin program to treat NASH,” said Oramed’s Chief Executive Officer, Nadav Kidron. “We also saw consistent trends across key secondary endpoints. This indicates that our oral insulin may be an ideal treatment option for the millions of diabetes and NASH patients, as the global market for drugs to treat NASH is expected to reach $84 billion by 20291. Using oral insulin to treat NASH opens a world of possibilities.”
As previously announced, the Phase 2 trial enrolled 32 patients (with 30 patients completing) over a treatment period of 12-weeks. The trial 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.
SOURCE: PR Newswire