Oramed Pharma (ORMP) Announces Additional Positive Safety and Efficacy Data from its Phase 2 Clinical Trial of ORMD-0801 for NASH
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Oramed Pharmaceuticals Inc. (Nasdaq: ORMP) (TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today announced additional positive data from its duplicate Phase 2 blinded, fully randomized, placebo-controlled, multicenter clinical trial (ORA-D-N02) to evaluate the safety and efficacy of its oral insulin candidate (ORMD-0801), for reducing liver fat content in patients type 2 diabetics with non-alcoholic steatohepatitis (“NASH”). The presentation of this new data, including a discussion by key opinion leaders, was the subject of a webinar today with a replay available on the Oramed website under Events and presentations.
Professor Yaron Ilan, MD, Director of the Department of Medicine at Hebrew University-Hadassah Medical Center and Principal Investigator of the clinical trial, commented: “Scientific results of ORMD-0801 clinical data demonstrated positive safety results on the main hepatic disorders. parameters such as reduction of fat and fibrosis. In this patient population, the safety of a potential treatment 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 Nadav Kidron, CEO of Oramed. “We also saw consistent trends on key secondary endpoints. This indicates that our oral insulin could 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. The use of oral insulin to treat NASH opens up a world of possibilities.”
Phase 2 trial resultsAs previously announced, the Phase 2 trial enrolled 32 patients (of which 30 patients completed) over a 12-week treatment period. The trial demonstrated that ORMD-0801 was safe and well tolerated at a dose of 8 mg twice daily, meeting the primary endpoint of no difference in adverse effects 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 measures included MR PDFF (%) measured by MRI, steatosis and fibrosis measured by Fibroscan, lipids and HbA1c. All measurements showed a consistent clinically significant trend in favor of ORMD-0801.
Summary of safety data
- The primary safety endpoint was achieved with no serious adverse events and no difference in adverse event incidence rate between ORMD-0801 and placebo.
Summary of efficacy dataOverall, the phase 2 trial achieved proof of concept that ORMD-0801 could be a potential candidate for the reduction of hepatic fat and stiffness and lipids in patients with T2D and NASH .
- Secondary objective of reduction in liver fat content in patients with NASH and T2DM (percentage change from baseline to week 12 in MR PDFF (%): – Whole liver showed a mean decrease adjusted for placebo of 0.96 with a placebo-adjusted median decrease of 6.0 for ORMD-0801.
- Exploratory objective of median change from baseline in Fibroscan fibrosis levels:- Median Change from Baseline at Week 12 in Median Fibrosis (kPa) showed a placebo-adjusted median decrease of 1.1 for ORMD-0801. – Median Change from Baseline at Week 12 in Steatosis Median (dB/m) showed a placebo-adjusted median decrease of 29 for ORMD-0801.
- Exploratory objective of change from baseline in lipid levels: – Mean change from baseline at week 12 in total cholesterol (mmol/L) showed a mean placebo-adjusted decrease of 0.40 for ORMD-0801.- The results were similar for LDL, HDL and Triglycerides.