Oramed Pharmaceuticals Inc., an Israel-based drug developer, has announced that clinical trial for its oral insulin capsule has showed promising results.
The company said, Thursday, that the Phase 2a clinical trial for the ORMD-0801, the oral insulin capsule that it has developed has met safety goals. The weeklong study involved patients with type 2 diabetes and was conducted under a new U.S. Food and Drug Administration (FDA) 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.
Oramed isn't the only drug company that is working on an alternative to insulin injections for the diabetics. The company is in race with Denmark's Novo Nordisk, Great Britain's GlaxoSmithKline and France's Sanofi to develop the world's first insulin pill. Oramed, however, has apparently moved ahead of the competition as it just announced the success of its Phase 2a clinical trial and its plan to launch a larger trial later this year.
"The results we announced today give us confidence about the chances of success in a bigger trial going forward," Kidron said. "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 next clinical trial, the Phase 2b, will run for one year and involve 150 type 2 diabetes patients to test the effectiveness of the drug. Kidron said that the 2a trial has already revealed that the drug was effective but the sample size was too small for FDA purposes.
The ORMD-0801 is targeted for individuals with early stages of type 2 diabetes. Oramed said that the orally ingestible insulin pill may slow the degeneration rate of the disease and make it easier for patients to start early treatment. The company also said that while the pill could not eliminate the eventual need for injections, it could at least delay it by many years.
The company would also have to conduct a Phase 3 trial before the drug hits the market so it will likely take years before the oral insulin pill becomes available.
