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

NEW YORK, NY, USA I September 17, 2018 I Oramed Pharmaceuticals Inc. (NASDAQ :ORMP ) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that 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," stated Nadav Kidron, CEO of Oramed.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed's Protein Oral Delivery (PODTM) technology is based on over 30 years of research by top scientists at Jerusalem's Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801). The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition, Oramed is developing an oral GLP-1 analog capsule (ORMD-0901).

SOURCE: Oramed Pharmaceuticals

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