Oramed Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has agreed to schedule an End-of-Phase II meeting with Oramed for its successfully completed Phase IIb trial of its oral insulin capsule ORMD-0801 in the treatment of type 2 diabetes. The Phase IIb trial met primary and secondary endpoints by indicating a statistically significant lowering of glucose relative to placebo.
The purpose of the End-of-Phase II meeting, which is expected to take place on August 31, 2017, is to review the Phase IIb results with the FDA and seek guidance from the regulatory agency on the clinical design and protocol of Oramed's upcoming pivotal Phase III trial, in preparation for filing a New Drug Application (NDA).
"Effective and safe oral insulin delivery can change and improve the way diabetes is treated today. We are very encouraged by the Phase IIb results and have been diligently developing our Phase III protocol. We look forward to a very productive meeting with the FDA," stated Oramed CEO Nadav Kidron.
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.