FDA Phase 2a results move Israeli pharmaceutical company one step closer to world’s first insulin pill.
Oramed Pharmaceuticals has announced successful results from its Phase 2a clinical trial for its ORMD-0801 oral insulin capsule for the treatment of type 2 diabetes. The trial – which met all primary and secondary endpoints — was conducted under a United States Food and Drug Administration (FDA) Investigational New Drug protocol. “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,” said Oramed CEO Nadav Kidron. “Following on the results from this type 2 diabetes study we are gearing up to start a multi-center Phase 2b study later this year. We are also excited about the potential of this drug for type 1 diabetes and plan to initiate a Phase 2a FDA study for this indication in the near term.” The Israeli developer of oral drug delivery systems included 30 patients with type 2 diabetes in its latest trial. Endpoints of safety as well as pharmacodynamic and pharmacokinetic effects were evaluated against a placebo control. The idea for oral insulin for diabetics has been around since the 1930s but pharmaceutical companies have found it difficult to create the perfect capsule due to the negative effect enzymes in the digestive system have on insulin. Oramed says it has created a solution that would allow the insulin to survive the destructive digestive juices. Oramed says its ORMD-0801 could reduce mealtime insulin doses and introduce a treatment regimen which would allow for fewer daily injections. The oral pill could also potentially slow the progression of the disease and halt insulin-dependence for patients.