Updated on 9 January 2013
Hope of diabetes patients - Oramed files IND with US FDA to start phase II clinical trial of orally ingested insulin
Singapore: Oramed Pharmaceuticals filed an Investigational New Drug (IND) application with the US FDA to begin a phase II clinical trial of its orally ingested insulin candidate, ORMD-0801. The trial is to include 147 type 2 diabetic patients in multiple centers across the US.
If Oramed does not receive comments from the FDA on the IND application within 30 days from filing, Oramed intends to immediately commence the trial to evaluate the safety, tolerability and efficacy of its oral insulin capsule on type 2 diabetic volunteers.
"This filing marks a major milestone for Oramed as it sets the ground for the largest trial on Oramed's oral insulin to date. We look forward to receiving FDA approval and initiating the phase II trial on Oramed's oral insulin candidate. Its success will ultimately present a pathway to a better treatment option for diabetic patients," commented Mr Nadav Kidron, CEO, Oramed.