Oramed Initiates Phase I Oral GLP-1 Study Under IND
- Category: Proteins and Peptides
- Published on Wednesday, 23 January 2019 11:12
- Hits: 748
JERUSALEM, Israel I January 22, 2019 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 it has begun recruitment for its Phase 1 pharmacokinetic (PK) study for ORMD-0901, its oral GLP-1 capsule. This is the first study of ORMD-0901 under Oramed's existing FDA Investigational New Drug application (IND). This is a fully-randomized, single-blind, placebo-controlled, 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.
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.
"We are pleased to announce the start of recruitment of this important study. 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 platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed's Protein Oral Delivery (POD™) technology is based on over 30 years of research by 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).
For more information, the content of which is not part of this press release, please visit www.oramed.com
SOURCE: Oramed Pharmaceuticals