Oramed announces successful Phase IIa clinical trial results

Israeli drugmaker Oramed Pharmaceuticals (NasdaqCM: ORMP) has announced positive results from the Phase IIa clinical trial for its ORMD-0801 oral insulin capsule for the treatment of type 2 diabetes.

The trial, conducted under a US Food and Drug Administration Investigational New Drug (IND) protocol, met all primary and secondary endpoints. Some 30 patients with type 2 diabetes took part in the trial in an in-patient setting for one week. Endpoints of safety as well as pharmacodynamic and pharmacokinetic effects were evaluated against a placebo control. Full results are expected to be presented at a scientific conference in the future.

Oramed chief executive Nadav Kidron said: “We are extremely pleased with the results which give a solid validation for Oramed’s platform technology in general and our oral insulin program in particular. Following on the results from this type 2 diabetes study we are gearing up to start a multi-center Phase IIb study later this year. We are also excited about the potential of this drug for type 1 diabetes and plan to initiate a Phase IIa FDA study for this indication in the near term.”