Cambridge, UK: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today’s therapies to enable healthier lives, announces that it has commenced the US Phase I clinical trial of Arecor’s lead product, AT247, an ultra-rapid insulin to be delivered by continuous subcutaneous infusion via insulin pump over a period of three days.
The trial is a double blind, randomised, three-way crossover study comparing the pharmacokinetics (PK) and pharmacodynamics (PD) of AT247 with Novo Nordisk’s NovoRapid® and Fiasp®, two market-leading rapid acting insulin treatments in 24 participants with type I diabetes. It will be the first trial to investigate the product’s potential when delivered by continuous subcutaneous infusion via insulin pump over a period of three days and follows a previous successful first-in-man clinical study.
AT247, a novel proprietary formulation of insulin, aims to accelerate insulin absorption, post injection, to enable more effective management of blood glucose levels for people living with diabetes. AT247 has the potential to significantly improve post prandial glucose control so avoiding episodes of both hypo and hyperglycemia. In a European Phase I clinical study in Type I diabetic patients published in 2021, AT247 exhibited an earlier insulin appearance, exposure, and offset, with corresponding enhanced early glucose-lowering effect compared with NovoRapid® and Fiasp®. This new trial is targeted for completion in H2 2022 and is expected to provide additional evidence that AT247 has the potential to facilitate a fully closed loop artificial pancreas, a potentially life changing treatment option for people living with diabetes.
Sarah Howell, Chief Executive Officer of Arecor, said: "We are excited to be initiating our first US clinical study that has been designed to further demonstrate the superiority of AT247 compared to current best-in-class insulins available to patients on the market today. Understanding the characteristics of AT247 when delivered via an infusion pump is important and may facilitate a fully closed loop artificial pancreas, transforming the lives of the c.537 million people living with diabetes.”
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).