Sydney-based Apollo Life Sciences has made a big step forward in its plan to bring a tablet form of insulin to market with Phase 1 toxicology trials proving successful.
Apollo's oral insulin consists of its oral delivery technology, Oradel, loaded with generic insulin. The treatment proved safe at both low and high doses.
The toxicology study was designed to test the safety of Apollo's oral insulin for people with diabetes. Oradel insulin was administered daily to two animal species for 14 days, followed by a 14-day recovery period. Control groups received treatment with the vehicle alone.
The key findings were that Oradel insulin caused no toxic effects or treatment-related changes in body weights, food consumption, blood analysis, urinalysis, gross necroscopy or histopathology.
"These favourable results provide strong supporting safety data for taking our oral insulin to Phase 1 human clinical trials, which we expect to undertake in the coming months," Apollo's science director, Dr Greg Russell-Jones, said in a statement.
"Our innovative oral insulin could mean the end of needles for many people with diabetes. It is only a matter of time before we enter the marketplace with our insulin in a tablet, and we believe that most people prefer to take a tablet instead of an injection."
For a profile of Apollo Life Sciences, see the March/April issue of Australian Life Scientist.
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