Oramed, a subsidiary of Jerusalem-based Oramed Pharmaceuticals, a developer of oral drug delivery systems, has retained Medpace as CRO for Oramed's upcoming phase II clinical trial on its oral insulin capsule, ORMD-0801.
The FDA-approved trial will assess the safety and efficacy of Oramed's oral insulin in 147 patients at multiple centers across the U.S. Oramed plans to file an IND with the FDA this quarter and commence the trial following approval.
Medpace will oversee the operation and data management of Oramed's phase II trial. Dr. David Orloff, Medpace's vice president of medical and regulatory affairs, is playing a major role in the design and implementation of the upcoming trial. Dr. Orloff is a past director of the FDA's Division of Metabolism and Endocrinology Products.