JERUSALEM May 18, 2016 — Oramed Pharmaceuticals Inc. (NASDAQ: ORMP), today announced positive top-line results from its Phase IIb study, designed to evaluate the safety and efficacy of its oral insulin capsule (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,” said Nadav Kidron, Oramed CEO. “We are delighted with the results and look forward to moving into Phase III trials.”
This 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.
“These are very impressive results that confirm the efficacy of orally delivered intestinally absorbed insulin,” said Dr. Michael Berelowitz, Head of Oramed’s Scientific Advisory Board. “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 plans to present and publish more comprehensive data in the future.
Conference Call today, May 18, at 11:00 am Eastern Time
Oramed will host a conference call to discuss the study results.
Interested parties may access the call at: +1-866-254-0808 (US) or +44-145-254-1003 (UK). Conference ID: 8327230