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January 30, 2014
05:57 EDTORMPOramed says Phase 2a ORMD-0801 study met all primary, secondary endpoints
Oramed Pharmaceuticals announced 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 FDA 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. 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."
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October 22, 2014
08:34 EDTORMPOramed's oral insulin capsules show positive Phase IIa results
Oramed Pharmaceuticals reported positive top-line clinical results from its Phase IIa clinical trial of ORMD-0801, the company's proprietary oral insulin capsules, to treat type 1 diabetes. The trial was conducted in the U.S. under an FDA Investigational New Drug protocol. The prospective, randomized, double-blind, placebo controlled study evaluated the safety and impact of ORMD-0801 given before meals on the exogenous insulin requirements in 25 established type 1 diabetic patients. ORMD-0801 oral insulin given before meals appeared to be safe and well-tolerated. Although the study was not powered to show statistical significance, there were internally consistent trends observed. The data showed a decrease in rapid acting insulin, a decrease in post-prandial glucose, a decrease in daytime glucose by continual glucose monitoring and an increase in post-prandial hypoglycemia in the active group.

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