FDA Clears Oramed’s Oral Insulin for Trial

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Oramed Pharmaceuticals Inc., a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule.

Oramed was founded by a group of scientists from Jerusalem’s Hadassah Ein Kerem Medical Center.  Dr. Miriam Kidron, who was part of that team, had been working for over twenty-five years on the development of oral insulin.  In 2006, the team had a breakthrough when they figured out how to correctly work the technology that would enable oral insulin to be effective. At that time, Nadav Kidron, the son of Miriam Kidron, decided it was time to bring this product to the market. Together with his mother, he founded Oramed.  ”When the technological basis seemed sound, I readily enlisted myself to help leverage the years of research toward commercializing this concept as soon as possible,” said Nadav.

The development of oral insulin has been no simple task.  “People have been dreaming about oral insulin since 1922,” Dr. Kidron said.  Because insulin is a protein, it’s easily broken down by enzymes in the digestive tract, just like any protein we eat.  An unprotected insulin tablet has no chance to do its job in the harsh environment of the gut.  And furthermore, insulin is a very large molecule, meaning it can’t be easily absorbed through the gut wall and circulated to the tissues where it is needed.

To combat these problems, Oramed has come up with a platform technology which can work not only with insulin, but with other peptides, like GLP-1 analogues (Byetta and Victoza are two current GLP-1 analog drugs on the market.)  Oramed’s technology provides protection against natural obstacles within the gastrointestinal tract, without jeopardizing the drug integrity and bioavailability.  The formulation involves a simple blend of insulin with protective reagents, provided at precisely calibrated concentrations and ratios.  Oramed’s drugs do not require any modification of active ingredients, so they can be administered in their natural state.  Because the technology doesn’t require changing the insulin molecule, the pre-marketing regulatory processes is shorter.

“We are very pleased to have the FDA clearance to proceed,” stated Nadav Kidron, CEO of Oramed. “The upcoming trial is a major milestone for Oramed and we look forward to continuing to progress ORMD-0801’s clinical development in the U.S.”

For more on Oramed see here.

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