Abstract #55 is available online.
Dr Eva Svehlikova, Medical Director of the Clinical Trials Unitat the Medical University of Graz and Investigator for the ARE-247-101 study, said: “AT247 has clearly demonstrated faster insulin absorption with an accelerated Pharmacokinetic (PK) and Pharmacodynamic (PD) profile compared to NovoRapid®and Fiasp®. AT247 has the potential to significantly improve postprandial glucose control and flexibility of insulin dosing. Potential clinical benefits for avoiding hypo and hyperglycaemia need to be confirmed in further clinical studies.This early evidence suggests that AT247 may facilitate a fully closed loop artificial pancreas, a potentially life changing treatment option for people living with diabetes.”
Oral Presentation of Abstract #55:
Phase I study investigating the PD, PK and safety of AT247 in comparison to insulin aspart and fast Insulin aspart
Presenting Author: Dr Eva Svehlikova
Session: OP10 Developing Better Insulins
Date and Time: Tuesday, 22 September, 2020, beginning at 14:30 CET
Sarah Howell, Chief Executive Officer of Arecor, added: “Presenting the successful results of our Phase 1 study of AT247 at EASD demonstrates the clear potential for our ultra-rapid acting insulin. We believe that AT247’s superior profile will improve both treatment and healthcare outcomes for people living with Type 1 diabetes. As treatment delivery systems continue to evolve, we believe that AT247’s favourable profile over current treatments may play a pivotal role in advancing the delivery of care, with the potential to enable the artificial pancreas, which could significantly reduce th eburden of self-management for people living with diabetes.”
AT247 is an investigational novel meal-time insulin formulation, that aims to significantly accelerate insulin absorption, post injection, to enable more effective management of blood glucose levels.It has been designed to achieve PK/PD properties that more closely match the physiological insulin mealtime response of a person without diabetes.
The double-blind, randomised, single dose, three-period cross over Phase I clinical study (EudraCT:2018-003934-34) compared the PK/PD profiles of AT247 to NovoRapid® and Fiasp® in 19 men with Type I diabetes. The trial was conducted in a glucose clamp setting at The Medical University of Graz and Joanneum Research in Austria, an internationally recognised centre of excellence in the field of diabetes research.
The PK/PD profile for AT247 was accelerated compared with both NovoRapid® and Fiasp®. AT247 was more rapidly absorbed from the injection site than both NovoRapid® and Fiasp®. Following dosing with AT247, insulin was detected in the blood 12 minutes (p=0.0004) earlier than following injection with NovoRapid®and 2 minutes (p=0.0003) earlier than following injection with Fiasp®. This earlier appearance in the blood was matched by a similarly significantly accelerated onset of glucose lowering action for AT247; 23 minutes (p=0.0004) earlier than NovoRapid® and 9 minutes (p=0.0006) earlier than Fiasp®. Importantly, the early (within 60 minutes) glucose lowering action after dosing with AT247 was fourfold (p=0.0004) greater than with NovoRapid® and two fold (p=0.0009) greater than with Fiasp®. No safety signals were detected.
The next step on the accelerated development pathway for AT247 will be to explore its potential as the ideal insulin for use in pump and fully closed loop delivery (artificial pancreas) systems. Current best-in-class insulins are simply not fast enough acting to adequately control blood glucose within the artificial pancreas system around meal-times. Therefore, there is a critical unmet need for even faster acting insulins, such as AT247, to enable a true artificial pancreas system which do not require a manual intervention by the patient around meal-times.
EASD holds its Annual Meeting in a different European city each year with more than 15,000 delegates from over 130 countries attending. The scientific programme includes more than 1,200 talks and presentations on the latest results in diabetes research by leading experts in the field.