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Oramed lists testees in first study under current FDA IND of oral GLP-1 capsule

Oramed Pharmaceuticals has started recruiting testees for its first study of oral GLP-1 capsule ORMD-0901 under Oramed’s existing FDA Investigational New Drug application (IND), in Phase 1 (PK) pharmacokinetic study.

This study will compare pharmacokinetics of ORMD-0901 to placebo and to open label Byetta (a GLP-1 analog currently on the market) in up to 15 healthy testees.

In the press release, the compny explained that glucagon-like peptide (GLP-1) analogs, which mimic the natural GLP-1 hormone in the body, are used in the treatment of type 2 diabetes and are currently only available via injection. In a prior Phase 1 study (in Israel) on type 2 diabetic patients, Oramed’s ORMD-0901 capsule was well tolerated and showed encouraging efficacy.

Nadav Kidron, CEO of Oramed expects initiating a broader Phase 2 study of ORMD-0901 in the U.S. in 2019.

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