Oramed Pharma, Medpace collaborate on phase II FDA trial of oral insulin
Oramed Ltd., a subsidiary of Oramed Pharmaceuticals, a developer of oral drug delivery systems, has signed an agreement to retain Medpace as a full-service 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 Investigative New Drug application (IND) with the FDA in this quarter and commence the trial following approval of the IND.
"We are excited about this collaboration, which represents a significant milestone for the company," said Nadav Kidron, CEO of Oramed. "After much due diligence, we decided to join forces with the experts at Medpace and look forward to working with them on the FDA-approved clinical trial of our oral insulin capsule."