Arecor Therapeutics plc announced that its ultra-concentrated, ultra-rapid acting insulin candidate, AT278, met all primary and secondary endpoints, and also demonstrated superiority to NovoRapid and Humulin R U-500, in a Phase I clinical trial in Type 2 diabetics with a high body mass index (BMI). AT278 (500 U/mL) is an ultra-concentrated, Ultra-rapid acting, novel formulation of insulin that accelerates the absorption of insulin post injection, even when delivered at a high concentration, and hence a lower injection volume. With no concentrated (>200 U/mL), rapid acting insulins on the market, AT278 has potential to be the first, and only, insulin available to the growing number of patients with high daily insulin requirements.

In the double-blind, randomised, two-way crossover study, the pharmacokinetic (PK)/pharmacodynamic (PD) and safety profiles of a single subcutaneous (SC) dose of 0.5 U/kg AT278 (500 U/mL) were compared with those of a single SC dose of 0.5 U/kg NovoRapid (100 U/mL), a currently available gold standard, rapid acting insulin treatment, in 39 participants with Type 2 diabetes within a BMI range of 25 and 39 kg/m2, in a euglycemic clamp setting. The PK/PD profile of 0.5 U/kg AT278 (500 U/mL) was also compared to a single SC dose of 0.5U/kg HumulinR U-500 (500 U/mL) in an open label manner. The trial met the primary endpoint of non-inferiority with respect to glucose lowering actions compared with NovoRapid.AT278 (500 U/mL) demonstrated a significantly accelerated (superior) early PK/PD profile compared to NovoRapid (100 U/mL), despite a 5-fold increase in concentration .AT278 (500 U/mL) demonstrated a significantly accelerated (superior) PK/PD profile compared to Humulin® R U-500 (500 U/mL), the only other insulin available at a concentration of 500 U/mL No safety signals were detected.