Oramed: Primary Safety & Efficacy Endpoints Met In Phase IIb Oral Insulin Study

(RTTNews) - Oramed Pharmaceuticals Inc. (ORMP) announced positive top-line results from its Phase IIb study, designed to evaluate the safety and efficacy of its oral insulin capsule or ORMD-0801 in patients with type 2 diabetes. The study's primary objective, a significant reduction of weighted mean night-time glucose, was successfully achieved.

"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," said Nadav Kidron, Oramed CEO.

The US based double blind, 28 day, randomized study of 180 adult type 2 diabetic patients showed a statistically significant decrease in the primary endpoint, pooled night-time glucose mean percentage change of 6.47% from run-in, between placebo and active cohorts (p=0.0268). The study additionally demonstrated a good safety profile with no drug related serious adverse events.

The company noted that it plans to present and publish more comprehensive data in the future.