Therapy Areas: Diabetes
Oramed wins US FDA clearance for IND application for ORMD-0901 to treat type 2 diabetes
18 September 2018 -

Pharmaceutical company Oramed Pharmaceuticals Inc (NASDAQ:ORMP) (TASE:ORMP) reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for human trials of ORMD-0901 for the treatment of type 2 diabetes.

The company is currently developing the oral GLP-1 analog capsule (ORMD-0901). The 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 currently only available via injection.

Under a prior Phase 1 study on type 2 diabetic patients, ORMD-0901 capsule was well tolerated and showed encouraging efficacy, including reducing blood sugar levels following a standard meal as compared to a placebo, added the company.

In conjunction, the company's proposed Phase 1 pharmacokinetic (PK) study is a fully-randomized, single-blind, placebo-controlled four way crossover study that will evaluate safety and the pharmacokinetics of ORMD-0901 compared to placebo and to open label Byetta, a GLP-1 analog, in up to 15 healthy subjects.

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