Arecor Therapeutics today (September 20) announced positive results from a phase 1 clinical trial of its rapid, concentrated insulin product.
The company’s candidate named AT278 is formulated using its Arestat technology and designed to significantly accelerate insulin absorption post injection. This is to enable more effective and convenient management of blood glucose levels in people with high daily insulin requirements.
Arecor Therapeutics’ AT278 for high insulin needs
Thomas Pieber, investigator for the ARE-278-102 study, said: “The rapid-acting characteristics of AT278, even with its five-fold increase in concentration, are clinically significant, suggesting that AT278 has the potential to significantly improve post prandial glucose control and reduce the number of daily injections for people with diabetes who have high insulin needs.”
In the double-blind, randomized, single dose, two-period cross over phase 1 clinical study the pharmacokinetic (PK) and pharmacodynamic (PD) profile of AT278 was compared to NovoRapid, the current gold standard treatment, in 38 patients with type 1 diabetes.
Glucose clamp
The trial was conducted in a glucose clamp setting at the Medical University of Graz and Joanneum Research in Austria, an internationally recognized center of excellence in the field of diabetes research.
The PK/PD profile for AT278 was accelerated compared with NovoRapid. Following dosing, AT278 showed a faster onset of insulin exposure compared with NovoRapid, as demonstrated by an earlier onset of appearance.
Fewer injections
Sarah Howell, chief executive officer of Arecor Therapeutics, said: “By enabling reduced injection volumes and fewer injections per day, whilst offering the potential for improved blood glucose control with its superior PK/PD profile, AT278 has the potential to become the gold standard insulin treatment for the growing population of people living with diabetes, who have high daily insulin needs, particularly those with type 2 diabetes.
A truly rapid acting concentrated insulin such as AT278 is also critical to the development of next generation miniaturized insulin delivery devices, where the size of such devices is often a barrier to use by patients.”