Arecor Limited, the biopharmaceutical company advancing today’s therapies to enable healthier lives, presented positive results for the Phase I clinical trial of its ultra-rapid acting insulin product candidate, AT247, at the American Diabetes Association 80th Scientific Sessions (ADA) virtual meeting. The abstract, #231-OR, is available on the ADA website.
Professor Thomas Pieber, Head of the Division of Endocrinology and Metabolism at the Medical University of Graz and Principal 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®. With a superior PK/PD profile to current best-in-class products such as Fiasp®, AT247 has the potential to significantly improve post prandial glucose control and flexibility of insulin dosing as well as the potential clinical benefits of avoiding both hypo and hyperglycaemia. AT247 also has the potential to enable a fully closed loop artificial pancreas, a potentially life changing treatment option for people living with diabetes.”
AT247 is an investigational novel mealtime 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.
AT247 Phase 1 Clinical Trial Results
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 twofold (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 a 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 mealtimes. 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 mealtimes.
Sarah Howell, Chief Executive Officer of Arecor, said: “The successful completion of our AT247 Phase I clinical study and selection for an oral presentation at ADA is an important landmark for Arecor. AT247 is under development as an ultra-rapid acting insulin targeted at improving treatment and healthcare outcomes for people living with Type I diabetes. In addition to the potential to improve post prandial blood glucose control, AT247 may play a critical role in advancing artificial pancreas systems. With AT247’s favourable profile over current treatments, we believe that our product has the potential to advance the diabetes treatment landscape.”