Oramed Reports Positive End of Phase 2 Meeting with the FDA for Oral Insulin

Oramed Pharmaceuticals announced the FDA provided positive feedback during the company's End of Phase 2 (EOP2) meeting for Oramed's oral insulin (ORMD-0801). Based on the FDA's feedback, Oramed intends to initiate two Phase 3 clinical trials following FDA review of those Phase 3 protocols, and nonclinical documents. The FDA outlined its expectations for design of the ORMD-0801 Phase 3 trials as well as submission of the Biologics License Application (BLA) that would follow successful trials. Oramed plans to conduct the two Phase 3 trials concurrently.

"We are very pleased with the results of our meeting with the FDA and look forward to submitting our finalized protocols for the Phase 3 trials to the FDA. Following successful Phase 3 trials, we would submit the BLA, which when approved would grant a full 12 years of marketing exclusivity for ORMD-0801. Based on our science and clinical trial results to date, we strongly believe our oral insulin product will address unmet needs among people with diabetes. Oramed is proud to be the global leader in bringing an oral insulin capsule towards commercial availability," Oramed's Chief Executive Nadav Kidron said.