Oramed Pharmaceuticals, a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, has announced that all follow-up visits in the company's Phase IIb study of its oral insulin capsule, ORMD-0801, have been completed.
The double-blind, randomized Phase IIb study of 180 patients with type 2 diabetes was initiated on June 30, 2015 and conducted at 33 clinical sites in the United States. The study was designed to generate ample data for both safety and efficacy endpoints. Top-line results are expected later this quarter.
"We are pleased with the successful and timely completion of this comprehensive study," stated Oramed CEO Nadav Kidron. "We look forward to reporting top-line results shortly."
About ORMD-0801 Capsule for Type 2 Diabetes
Intestinally-absorbed oral insulin mimics insulin's natural location and gradients in the body by first passing through the liver before entering the bloodstream. 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 eliminating late-stage complications. Orally administered insulin is also expected to enhance patient compliance.