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news.Israel-based Oramed Pharmaceuticals has enrolled the first patient in its Phase IIb of its oral insulin capsule, ORMD-0801, for the treatment of type 2 diabetes.
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This US based trial will be conducted under the active investigational new drug (IND) application on file with the US Food and Drug Administration (FDA).
Around 180 patients will be enrolled in this double-blind, randomized Phase IIb trial, which is designed to generate ample data for both safety and efficacy endpoints.
Oramed CEO Nadev Kidron said: "This pivotal study is a huge step for Oramed, as it will enable us to demonstrate the potential of our oral insulin capsule in a large clinical study. We look forward to completing the study and presenting the data collected."
The company noted that ORMD-0801 has the potential to create a new concept in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment.
ORMD-0801 is expected to potentially slow disease progression and delaye or even eliminate late-stage complications. Orally administered insulin is expected to bring result in improved patient compliance.
Additionally, intestinally absorbed-oral insulin actually mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.