Oramed Receives FDA Clearance for IND Application for Its Oral GLP-1 Analog Capsule

Oramed Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for human trials of its oral GLP-1 analog capsule ORMD-0901.

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

Oramed's planned Phase 1 pharmacokinetic (PK) study is a fully-randomized, single-blind, placebo-controlled 4-way crossover study which will evaluate safety in addition to the pharmacokinetics of ORMD-0901 compared to placebo and to open label Byetta, a GLP-1 analog currently on the market, in up to 15 healthy subjects.

"We are pleased to receive the FDA's clearance of our IND and we plan to initiate this small PK and dosing study in the current quarter. Upon its completion, we anticipate initiating a broader Phase 2 study of ORMD-0901 in the U.S. in 2019," said Nadav Kidron, CEO of Oramed.

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