Oramed's Phase IIb Oral Insulin Study Meets Primary Safety And Efficacy Endpoints

Oramed Pharmaceuticals Inc.

, disclosed Wednesday the positive top-line results from its Phase IIb study, which was meant to evaluate the safety and efficacy of its oral insulin capsule in patients with type 2 diabetes. According to the company, the trial's principal goal, a significant drop of weighted mean night-time glucose, was achieved successfully. The company's CEO, Nadav Kidron, was obviously pleased to say, "This demonstration of safe and effective oral insulin delivery represents a transformative event in the treatment of type 2 diabetes. We are delighted with the results and look forward to moving into Phase III trials." Oramed said that this double blind, 28 day, randomized trial of 180 adult type 2 diabetic patients demonstrated a statistically significant drop in the primary endpoint, pooled night-time glucose mean percentage change of 6.47 percent from run-in, between placebo and active cohorts. Additionally, the trial also demonstrated a good safety profile with no drug related serious adverse events. Commenting on the developments, Head of Oramed's Scientific Advisory Board, Michael Berelowitz, said, "These are very impressive results that confirm the efficacy of orally delivered intestinally absorbed insulin. The promise of this more physiological delivery system for insulin is the inhibition of hepatic glucose production, which was clearly demonstrated via the significant reduction in night-time glucose levels in patients who received ORMD-0801." The Company indicated that it intends to present, as well as, publish more comprehensive data in the future. On Tuesday, the stock traded 5.64 percent lower.