Arecor Therapeutics PLC (AIM:AREC) said the Austrian regulator has given the go-ahead for an EU phase I clinical trial of A278, the company’s rapid-acting, ultra-concentrated insulin discovery.
It is expected the study, which will be carried out at the Medical University of Graz, will get underway next month. The initial read-out is currently slated for the fourth quarter of next year.
Researchers will assess the drug’s pharmacokinetic (PK) and pharmacodynamic (PD) profiles (the way it interacts with the body) in 32 sufferers of Type-2 diabetes.
It will do so using by comparing the Arecor asset with NovoRapid, a product already out in the market.
It is already shown to have accelerated PK and PD profiles in Type-1 diabetes patients when compared with NovoRapid and was more rapidly absorbed than the currently marketed treatment.
“With its very promising profile already demonstrated in our previous study, AT278 has the potential to disrupt the market for insulin treatment as the first concentrated, yet very rapid-acting insulin and to become the gold standard insulin for the growing population of people with diabetes with high daily insulin needs as well a critical enabler in the development of next-generation miniaturised insulin delivery systems,” said chief executive Sarah Howell.
Separately, Arecor said it won patent protection for the unique formulation of its ultra-rapid action insulin products AT247 and AT278 in Japan and South Korea.
It follows the patent grant secured in the US earlier this year.
Arecor chief scientific officer Dr Jan Jezek said the Japan and Korea patents marked a significant milestone for the business.
AT247 has the potential to power an artificial pancreas, while AT278 could, the company believes, become the gold standard for use in people with diabetes.
The two products are designed to give Arecor a toe-hold in the US$6bn+ a year artificial insulin market.