Oramed Pharmaceuticals Reports Positive Top-Line Data From U.S. Phase IIa Trial With Oral Insulin In Type 1 Diabetes

Oramed Pharmaceuticals Inc.

(http://www.oramed.com ), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today reported positive top-line clinical results from its Phase IIa clinical trial of ORMD-0801, the company's proprietary oral insulin capsules, to treat type 1 diabetes. The trial was conducted in the United States under a U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) protocol. The prospective, randomized, double-blind, placebo controlled study evaluated the safety and impact of ORMD-0801 given before meals on the exogenous insulin requirements in 25 established type 1 diabetic patients. The primary endpoint of the study was the change from baseline in exogenous insulin requirements (basal, bolus and total) in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo. The secondary endpoint of the study was the change from baseline in mean nighttime, daytime and fasting glucose levels (by continuous glucose monitoring) in patients treated with ORMD-0801, compared to the change from baseline for patients treated with placebo. The results showed that ORMD-0801 oral insulin given before meals appeared to be safe and well-tolerated for the dosing regimen in this study. Although the study was not powered to show statistical significance, there were internally consistent trends observed. Consistent with the timing of administration, the data showed a decrease in rapid acting insulin, a decrease in post-prandial glucose, a decrease in daytime glucose by continual glucose monitoring and an increase in post-prandial hypoglycemia in the active group. "We are very pleased with the outcome of this study and look forward to sharing it with the scientific community," commented Miriam Kidron, Ph.D., Chief Scientific Officer of Oramed. "We continue to build our body of human clinical data in support of the use of ORMD-0801 to treat both type 1 and type 2 diabetes. With the data gathered so far, we look forward to initiating our Phase IIb study of ORMD-0801 in type 2 diabetes patients later this year." The company intends to hold a conference call on November 3rd, 2014 at 10:00 a.m. Eastern Time to present detailed data from the study. More details to follow.