Oramed Submits Protocol To US FDA For Phase11B Oral Insulin

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that it has submitted the study protocol for the company's Phase IIb trial of ORMD-0801, its oral insulin capsule, to the U.S. Food and Drug Administration (FDA). The submission was made under the company's existing Investigational New Drug (IND) application.The Phase IIb study of ORMD-0801 for type 2 diabetics is designed to generate ample data for both efficacy and safety endpoints. The double-blind, randomized study will recruit approximately 180 patients and has a 28-day treatment period. The study has already received Institutional Review Board (IRB) approval and patient enrollment is expected to start in the short term.