Oramed files IND with FDA to begin ORMD-0801 Phase 2 trial for type 2 diabetes
Published on January 9, 2013 at 1:18 AM
Oramed Pharmaceuticals Inc. (OTCBB:ORMP.OB) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of its orally ingested insulin candidate, ORMD-0801. The IND application was filed with the FDA on December 31, 2012. The trial is to include 147 type 2 diabetic patients in multiple centers across the United States. If Oramed does not receive comments from the FDA on the IND application within 30 days from filing, Oramed intends to immediately commence the trial to evaluate the safety, tolerability and efficacy of its oral insulin capsule on type 2 diabetic volunteers.
According to the 2011 National Diabetes Fact Sheet as reported by the Centers for Disease Control and Prevention (CDC) nearly 8.3% of Americans had diabetes in 2010 - approximately 25.8 million people. The same report noted that the 2007 expense for diabetes treatment in the Unites states was $174 billion, with direct costs for treatment representing $116 billion - a number that is 2.3 times higher than the medical costs of someone who does not have diabetes.
"This filing marks a major milestone for Oramed as it sets the ground for the largest trial on Oramed's oral insulin to date. We look forward to receiving FDA approval and initiating the Phase 2 trial on Oramed's oral insulin candidate. Its success will ultimately present a pathway to a better treatment option for diabetic patients," commented Nadav Kidron , CEO of Oramed.
Oramed Pharmaceuticals Inc.