Oramed’s oral insulin capsule has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin.
Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical Company focused on the development of oral drug delivery systems, announced today that the first patient has been screened in the Company’s Phase IIb trial of its oral insulin capsule, ORMD-0801.
This U.S. based study will be performed under the active Investigational New Drug (IND) application on file with the U.S. Food and Drug Administration (FDA).
The Phase IIb study for type 2 diabetes is designed to generate ample data for both safety and efficacy endpoints. The double-blind, randomized study will recruit approximately 180 patients.
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Oramed CEO, Nadev Kidron, made the following statement:
“This pivotal study is a huge step for Oramed, as it will enable us to demonstrate the potential of our oral insulin capsule in a large clinical study. We look forward to completing the study and presenting the data collected.”
About ORMD-0801 Capsule for Type 2 Diabetes
ORMD-0801 has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment, potentially slowing disease progression and delaying or even eliminating late-stage complications. Orally administered insulin is expected to bring result in enhanced patient compliance.
In addition, intestinally absorbed-oral insulin actually mimics insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.
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 (POD[TM]) 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). Having completed multiple Phase IIa clinical trials, the company has started its Phase IIb on type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition the company is developing an oral GLP-1 analog capsule (ORMD-0901).
Source: Oramed Pharmaceuticals