Pharmaceutical companies have poured millions—maybe billions—of dollars into research aimed at finding a way to deliver insulin to patients by mouth. More than 500 million people worldwide have diabetes, and for those who need insulin, a pill or capsule would be a godsend. Until now, insulin was only available via injection or an inhaler.
But one company working to change that may be on to something. Oramed Pharmaceuticals Inc. (ORMP, Financial), a clinical-stage pharmaceutical company with offices in New York City and Israel, has achieved promising results in early tests of the safety and efficacy of its lead oral insulin capsule, ORMD 0801.
These data suggest the first commercial oral insulin to treat types 1 and 2 diabetic patients could be on the horizon, according to an article in Forbes, which said the development “might be the game-changer that revolutionizes the treatment of diabetes.”
An oral pill for insulin will make it easier for the patients to take insulin, Samir Mitragotri, a professor of bioengineering and biologically inspired engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences, told CNN.
“Not only does oral insulin offer a more convenient alternative to needles, a therapy many patients are reluctant to begin, but it also provides a more efficient and safer platform for delivering insulin by mimicking the body’s natural process of insulin going directly to the liver rather than via the bloodstream,” Oramed CEO Nadav Kidron said.
Micro-cap Oramed has a market value of about $78 million. In its 13 years as a public company, it has traded as high as $22; the stock is currently at $3.35, down more than 30% this year.
On Feb. 27, the company announced the pricing of an underwritten public offering of 5.25 million shares of its common stock at a public offering price of $4 per share. Proceeds are expected to be $21 million.
Of course, the landscape is littered with companies that have tried to develop an insulin pill and failed. Until now, the efforts were stymied by two main hurdles. First, a pill degrades during oral digestion. Second, the size of the insulin is too large to get inside the bloodstream unless it is injected.
The Oramed pill uses enteric coated insulin that remains intact through the gastrointestinal tract and reach the intestinal wall. The company said its Protein Oral Delivery technology is based on more than 30 years of research by scientists at Jerusalem's Hadassah Medical Center.
Kidron said the company is looking forward to discussing with the Food and Drug Administration the company’s phase 3 trials. “We are additionally very pleased with the progress of our Chinese partners, HTIT, who will also be initiating phase 3 trials for our oral insulin and might even become the first to reach commercialization."
Disclosure: The author has no position in Oramed.
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