JERUSALEM, November 12, 2013 /PRNewswire/ —
Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the last patient has left the clinic from its U.S. FDA Phase 2a safety study for ORMD-0801, an oral insulin capsule based on the Company’s platform Protein Oral Delivery (POD™) technology.
The Phase 2a trial, which enlisted 30 type 2 diabetes patients in an in-clinic setting for a seven-day period, was implemented in response to FDA feedback requesting a safety study on ORMD-0801 prior to initiating a larger multi-center trial in the US.
“We are thrilled to announce the last patient out of our Phase 2a clinical trial under the FDA. We look forward to announcing the results,” said Oramed CEO Nadav Kidron.
About ORMD-0801 Oral Insulin
Oramed’s ORMD-0801 is an orally ingestible insulin capsule indicated for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite. Moreover, orally administered insulin has the potential benefit of enhanced patient compliance at this crucial stage as well as the advantage of mimicking insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream. For more information on ORMD-0801, the content of which is not part of this press release, please visit http://oramed.com/index.php?page=14
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top research 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) currently in Phase 2 clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), with trials on healthy volunteers (Phase 1b) and T2DM patients (Phase 2a) underway. Oramed is also moving forward with clinical trials of ORMD-0801 for the treatment of type 1 diabetes. The company’s corporate and R&D headquarters are based in Jerusalem.
For more information, the content of which is not part of this press release, please visit http://www.oramed.com
