Arecor Therapeutics plc announced that the American Diabetes Association journal, Diabetes Care, has published data from the Company's Phase I clinical trial of AT278, its ultra-concentrated (500 U/mL), ultra-rapid acting insulin product candidate. The manuscript, titled 'Pharmacokinetics and Pharmacodynamics of a Novel U500 Insulin Aspart Formulation: A Randomized, Double-Blind, Crossover Study in People with Type 1 Diabetes', is now available online. In the Phase I clinical study in people with Type I diabetes, AT278 (500 U/mL) clearly demonstrated faster insulin absorption with an accelerated pharmacokinetic (PK) and pharmacodynamic (PD) profile compared to gold-standard insulin NovoRapid® (100 U/mL) despite a 5-fold increase in concentration.

AT278 is an ultra-concentrated (500 U/mL) novel formulation of insulin that has been designed to accelerate the absorption of insulin post injection, even when delivered at a high concentration, and hence via a lower injection volume. Currently, there are no concentrated (>200 U/mL) rapid acting insulin products on the market, and therefore, AT278 has the potential to be the first such product available to patients. It has the potential to enable more effective management of blood glucose levels to the increasing number of people with diabetes with high daily insulin requirements (>200 units/day) whilst maintaining the convenience and compliance benefits of being able to deliver these high insulin doses in a lower injection volume via a single injection.

In addition, a truly rapid acting concentrated insulin is also a critical step towards the advancement and miniaturisation of the next generation of insulin delivery devices. AT278 is also currently being investigated in a second Phase I trial in patients with Type 2 diabetes, to further explore the product's potential to disrupt the market as the first concentrated, yet rapid acting, insulin. The study initiated earlier this month and is expected to complete within fourth quarter of 2023.