Arecor Therapeutics PLC (AIM:AREC) said its ultra-concentrated, rapid-acting insulin formulation hit its primary goal in a phase I clinical trial.
AT278 was pitted against a product called NovoRapid in the early-stage evaluation, which assessed pharmacokinetics (the time taken for the drug to be absorbed and distributed), pharmacodynamics (the treatment’s effects) and safety.
The so-called ‘primary endpoint’ of the double-blind, randomised study, which involved 38 sufferers of type I diabetes, was ‘non-inferiority’ to the gold-standard treatment in lowering glucose.
However, the Arecor discovery also demonstrated a significantly accelerated early pharmacokinetic/pharmacodynamic profile compared with NovoRapid despite a five-fold concentration. Researchers detected no safety issues.
AT278 is being developed to overcome a key challenge tackling diabetes. Typically, increasing the concentration of insulin results in slower absorption and delayed glucose lowering.
Chief executive Sarah Howell told investors: "The successful completion of our AT278 phase I clinical trial is an important milestone for Arecor.
“AT278 has the potential to disrupt the market for insulin treatment in people with diabetes, as the first concentrated, yet rapid-acting, insulin - a critical enabler in the development of next-generation miniaturised insulin delivery systems.”
The company said the next step will be “further clinical investigation of the potential benefits of the ultra-rapid acting profile of AT278 to further optimise the positive results obtained in this first clinical study”.