The patent, titled ‘Methods and Compositions for Oral Administration of Exenatide’, covers oral exenatide compositions made using Oramed’s proprietary technology, including its ORMD-0901 oral exenatide capsule.
The company has planned a comprehensive clinical program for ORMD-0901, with the goal of seeking approval in the US and other territories.
According to the company, IND-enabling toxicity studies are expected to start later in 2014 in the US and a Phase 1b trial outside of the US is also scheduled for 2014.
The company is focused in the field of oral delivery solutions for drugs and vaccines currently delivered via injection.
Oramed is seeking to revolutionize the treatment of diabetes through its orally ingestible insulin capsule (ORMD-0801) currently in Phase II clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the US FDA, and with its oral GLP-1 analog capsule (ORMD-0901).
The company is also moving forward with clinical trials of ORMD-0801 for the treatment of type 1 diabetes.