Oramed Pharmaceuticals' ORMD-0801 Phase 2a study meets primary and secondary endpoints

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP), a developer of oral drug delivery systems, announced today results from its Phase 2a clinical trial for its ORMD-0801 oral insulin capsule for the treatment of type 2 diabetes. The trial was conducted under a United States Food and Drug Administration (FDA) IND (Investigational New Drug) protocol. The Phase 2a study met all primary and secondary endpoints.

30 patients with type 2 diabetes took part in the trial in an in-patient setting for one week.  Endpoints of safety as well as pharmacodynamic and pharmacokinetic effects were evaluated against a placebo control.  For full information on the Phase 2a trial design and endpoints please see Clinical Trials*.  Further information on the safety results of the Phase 2a clinical trial can be found on Oramed's website. Full results are expected to be presented at a scientific conference in the future.

"We are extremely pleased with the results which give a solid validation for Oramed's platform technology in general and our oral insulin program in particular," stated Oramed CEO Nadav Kidron. "Following on the results from this type 2 diabetes study we are gearing up to start a multi-center Phase 2b study later this year.  We are also excited about the potential of this drug for type 1 diabetes and plan to initiate a Phase 2a FDA study for this indication in the near term."