Oramed Pharmaceuticals has signed an agreement with Medpace to retain the latter as a CRO for Oramed's forthcoming Phase II 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 centres across the US. Oramed plans to file an IND with the FDA shortly, and begin the trial following approval of the IND.
Medpace will oversee the entire 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 forthcoming trial. Orloff is a past Director of the FDA's Division of Metabolism and Endocrinology Products and, Oramed believes, with Medpace's standards as a CRO, is well-positioned to advance the most efficient and cost-effective path to drug approval for Oramed.