Oral drug delivery systems developer Oramed Pharmaceuticals has submitted a pre-Investigational New Drug (pre-IND) seeking approval from the US Food and Drug Administration (FDA) to commence a trial on its orally ingestible exenatide capsule, ORMD-0901.
Oramed CEO Nadav Kidron commented that the pre-IND meeting request letter is part of its efforts to advance ORMD-0901 into US clinical trials.
"We look forward to the FDA's response and preparing ourselves accordingly in our efforts leading up to full IND submission on our second product," Kidron added.
Oramed's proprietary flagship product ORMD-0801, an orally ingestible insulin capsule, is currently being initiated to Phase II clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the FDA.
The company's oral exenatide capsule (ORMD-0901; a GLP-1 analog) is underway in trials on healthy volunteers (Phase 1b) and T2DM patients (Phase 2a).
