Oramed Completes Randomization of Over 50% of Patients in Phase IIb Study
Oramed Pharmaceuticals Inc. recently announced that 98 patients have already been enrolled in the company’s Phase IIb study of its oral insulin capsule, ORMD-0801, which represents more than 50% of the 180 patients expected to be recruited for the trial. The double-blind, randomized Phase IIb study for type 2 diabetes was initiated on June 30 and is designed to generate ample data for both efficacy and safety endpoints.
“We are extremely pleased with the pace of patient enrollment in the trial, which is in line with our expectations. The principal investigators and clinics participating in the trial include some of the most prestigious in the United States,” saidd Oramed CEO Nadav Kidron.
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 should bring with it 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.
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) 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). For more information, visit www.oramed.com.
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