JERUSALEM, May 18, 2016 /PRNewswire/ — 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 FREE (US) or +44-145-254-1003 (UK). Conference ID: 8327230
About the Phase IIb Oral Insulin Study
The double-blind, randomized Phase IIb study of 180 patients with type 2 diabetes was initiated on June 30, 2015 and was conducted at 33 clinical sites in the United States under an IND that was approved by the FDA. The study was designed to generate data to assess the safety and efficacy of multiple oral bedtime doses of ORMD-0801 in adult patients with type 2 diabetes mellitus who are inadequately controlled with diet and metformin. The study was comprised of three arms: placebo, ORMD-0801 16mg and ORMD-0801 24 mg. Patients were dosed before bed-time, and their night-time glucose levels (6 hours post dose) were continuously monitored.
For more information on the study, which does not form a part of this press release, see: https://clinicaltrials.gov/ct2/show/NCT02496000?term=oramed&rank=5
ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications. Orally administered insulin is expected to enhance patient compliance. In addition, intestinally absorbed-oral insulin mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD[TM]) technology is based on over 30 years of research by scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).