Oramed Pharmaceuticals (NSDQ:ORMP) said today that the FDA scheduled an end-of-phase II meeting with the Jerusalem-based company for August 31.
Oramed is developing an oral insulin capsule for the treatment of Type II diabetes. The company’s Phase IIb trial met primary and secondary endpoints, since the insulin capsule lowered patients’ blood sugar relative to a placebo.
At the company’s meeting with the FDA, Oramed is slated to review the results from the Phase IIb trial and receive guidance regarding the design and protocol for its pivotal Phase III trial.
“Effective and safe oral insulin delivery can change and improve the way diabetes is treated today. We are very encouraged by the Phase IIb results and have been diligently developing our Phase III protocol. We look forward to a very productive meeting with the FDA,” Oramed CEO Nadav Kidron said in prepared remarks.
