30.01.2014 10:09:58
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Oramed Pharma To Move Forward With FDA Phase 2b Multi-Center Study - Quick Facts
(RTTNews) - Oramed Pharmaceuticals Inc. (ORMP), a developer of oral drug delivery systems, reported Phase 2a trial results for its ORMD-0801 oral insulin capsule for type 2 diabetes treatment. The study was conducted under a United States Food and Drug Administration or FDA Investigational New Drug or IND protocol. The Phase 2a trial met all primary and secondary endpoints.
According to the company, 30 patients with type 2 diabetes participated in the study in an in-patient setting for one week. Endpoints of safety as well as pharmacodynamic and pharmacokinetic effects were evaluated against a placebo control.
Oramed's Chief Executive stated: "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."
The complete results are likely to be presented at a scientific conference in the future.
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