Oramed Pharmaceuticals Inc. announced detailed results from its previously completed Phase 2a trial investigating ORMD-0801, its orally ingestible insulin capsule, in type 2 diabetes patients. The preliminary results of this trial were originally announced on Jan. 30, 2014.
The detailed results were presented Thursday by Oramed’s Chief Scientific Officer, Dr. Miriam Kidron, at the 2014 GTC Diabetes Summit, taking place in Cambridge, Massachusetts. The trial was conducted in the United States under a Food and Drug Administration (FDA) Investigational New Drug (IND) protocol.
The results showed that ORMD-0801 oral insulin appeared to be safe and well-tolerated for the dosing regimen considered in this study. No hypoglycemic events occurred at any point in any treatment group and no treatment related adverse events were observed. Although the study was not powered to show statistical significance, there were trends observed showing pattern of well-defined and short-term increases in plasma insulin and decreases in blood glucose.
“We are very pleased with the outcome of this study, which showed ORMD-0801 to be safe and well-tolerated,” stated Dr. Miriam Kidron, Chief Scientific Officer of Oramed. “Importantly, the decreases in blood glucose we observed were not associated with any hypoglycemic events. We look forward to moving ahead with our planned U.S. Phase 2b trial in individuals with type 2 diabetes which will investigate ORMD-0801 over a longer treatment period and which will have statistical power to give us greater insight into the drug’s efficacy.”
The detailed results, which include study design, safety results, pharmacodynamics and pharmacokinetics, are available online. (http://www.oramed.com/ufiles/Oramed%20GTC%20data%20presentation.pdf)
Date: April 24, 2014