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First Oral Insulin for Diabetics Takes Major Step Towards FDA Approval
New York-based Oramed begins its largest clinical trial to date under FDA, recruiting type 2 diabetics across the country
Oral insulin, the Holy Grail of diabetes care that has alluded researchers for decades, is taking a major step towards becoming reality.
Oramed Pharmaceuticals Inc. (NASDAQ/TASE: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, is working to bring the first oral insulin product to market, providing a more convenient, effective and safer method for delivering insulin therapy.
The company has launched its largest and most advanced clinical trial under direction of the U.S. Food and Drug Administration (FDA) to date, involving 240 patients with type 2 diabetes in multiple centers throughout the U.S., including the CHEAR Center in the Bronx.
Oramed’s oral insulin is currently in a pivotal clinical study going through FDA regulatory channels and is considered a game-changer for the more than 100 million American adults living with diabetes or prediabetes.
“Our oral insulin is solving the drawbacks to injectable insulin, delivering it in a way that a needle could never replicate,” said Oramed CEO Nadav Kidron. “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.”
The trial participants will take the oral pill for 90-days, with different groups following different dosing regimens at varying times throughout the day. The study is designed to show the product’s effectiveness at lowering glycated hemoglobin, a determinant of average blood sugar levels over three months and is considered the gold standard by the FDA when evaluating the drug’s efficacy.
As Kidron explained, early insulin therapy is ideal in order to decrease the burden on a diabetic’s pancreas, potentially allowing it to continue producing insulin for longer. However, doctors are often cautious when prescribing insulin by injection because it is a complex process that relies on patient compliance. Not only is there a danger of injecting too much insulin, but because the insulin is introduced directly into the bloodstream, only a fraction reaches the liver, often causing excess sugar to be stored in fat and muscle which results in weight gain. For this reason, injectable insulin is often viewed as a last resort.
With Oramed’s proprietary platform, the active insulin is protected as it travels through the stomach and into the intestine, and its absorption is increased along the intestinal wall. The result is better glucose control, reduced hyper and hypoglycemia, and less weight gain. In addition, oral insulin is easier for diabetics to incorporate into their daily routine because they simply take a pill, removing the need for multiple daily injections and continual glucose measurements.
“Right now, we know there are diabetics who would benefit with early insulin therapy who are simply not getting it due to the fact that, today, it is only available as an injection,” said Kidron. “By providing insulin in an effective pill form, we’re removing the barriers from both the physician and patient perspectives.”
An earlier trial for Oramed’s oral insulin – involving 180 patients across the U.S. over 28 days – demonstrated strong promise for the technology, showing it to be a safe oral insulin delivery method with no serious adverse events related to the treatment. It also demonstrated a significant ability to lower glucose levels, including the glycated hemoglobin gold standard. The current trial – the first to be conducted over 90 days – is hoped to show an even greater impact.
“This is our most important study to date,” Kidron said. “A year from now we will better know the potential of our drug to control and maintain blood glucose levels and will have further proof of the longer-term benefits of taking an oral pill versus an injection.”
David B. Bernard, MD, Principal Investigator at the CHEAR Center, called the clinical trial an important step forward in diabetes management. “We strongly believe that oral insulin will lead to better compliance and ultimately, healthier patients,” said Dr. Bernard, noting that the center sees approximately 250 diabetes patients each year for clinical study-related purposes.
Data from the current U.S.-based clinical trial will be available early next year and should set the stage for final FDA studies needed prior to approval.
Seeing the product through to market will be particularly satisfying for Kidron, who co-founded the company in 2006 as a means to bring a discovery made by his mother, Miriam Kidron – a former researcher at Hadassah-Hebrew University Medical Center in Jerusalem and current Chief Scientific Officer at Oramed – out of the lab and into the hands of diabetics.
My father suffered from diabetes and it was my mother’s mission to find an alternative way to deliver insulin,” said Kidron. “When she told me that they had a breakthrough that could help millions of people around the world, that’s when I knew I had to make it a reality.”