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| Oral insulin: clinical human trials, here we come... |
No more needles | Apollo’s insulin in a tablet is a step closer to becoming a reality after a final toxicology study report showed it to be safe at extremely high doses.
Apollo has been working to develop oral insulin so that people with diabetes will not need injections. Many people with the disease have to inject themselves with insulin up to five times a day.
Apollo’s oral insulin is made up of the company’s oral delivery technology, Oradel™, loaded with generic insulin. Oradel™ protects the insulin from being broken down in the stomach, and ensures it is absorbed from the gut into the bloodstream.
The results of the toxicology study were released in January and showed that Oradel™ insulin caused no toxic effects or other problems in any of the areas that need to be examined before a drug can progress to human trials.
“We tested Oradel™ insulin at two dosage levels. One was the expected treatment dose and the other was a massive dose, well beyond what would ever be used in practice. There were no signs of toxicity, even at the largest doses,” said Dr Russell-Jones.
Apollo’s Executive Chairman, John Priest, said “Apollo believes people with diabetes would prefer to take a tablet than have an injection, so Oradel™ insulin will be preferred.”
Oradel™ insulin has a large potential market, with over 246 million people diagnosed with the disease worldwide and the global market for medicines for people with diabetes valued at about $18 billion per annum.
Apollo is now set to take its oral insulin to Phase 1 human clinical trials and these are expected to roll out over the coming months.
“This will be a very important step for Apollo. We believe our oral insulin has enormous potential and we’re excited by how it will perform in trials,” said Mr Priest.
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| www.apollolifescience.com |
