Arecor Limited (“Arecor” or “the Company”), the biopharmaceutical company advancing today’s therapies to enable healthier lives announces dosing of the first patient in a Phase I clinical trial for its second clinical stage product, an ultra-concentrated rapid acting insulin, AT278.
AT278 is a novel proprietary formulation of concentrated insulin (500U/mL) that is designed to maintain rapid-acting characteristics in a reduced volume, thereby enabling fast absorption into the bloodstream from the site of injection.
Sarah Howell, Chief Executive Officer at Arecor, said: “The initiation of the Phase I clinical trial for AT278, is key to the advancement of our diabetes franchise of superior fast acting insulins, focused on more personalised treatment regimens and sophisticated drug/device combinations. AT278 presents a significant step towards helping people with diabetes to maintain glucose control safely and conveniently. A concentrated rapid acting insulin is a key enabler to delivering the next generation of miniaturized insulin delivery systems as well as providing a superior treatment and quality of life for people requiring large daily doses of insulin to manage their condition. I look forward to reporting on the progress of AT278 next year.”
Earlier therapeutic interventions, coupled with longer lifespans, has increased resistance of the body to insulin and created the need for a higher daily dose of insulin for some patients with diabetes. In addition, the proportion of patients with diabetes with high body mass index (BMI) is increasing; these patients also require higher daily doses of insulin. A concentrated rapid acting insulin is preferred for these patient groups.
Next-generation device technology such as miniaturised wearable and continuous administration patch pumps are critical future developments for people living with diabetes, improving glycemic control and compliance, thus reducing adverse states such as hypoglycaemia and diabetic ketoacidosis (DKA), as well as overall complications and mortality. A rapid-acting ultra-concentrated insulin is a critical unmet need to enable these next generation delivery systems, in addition to reducing the number of daily injections for insulin resistant patients requiring high doses of insulin.
The availability of concentrated, rapid acting insulin will reduce the volume of insulin to be administered and will benefit diabetic patients through:
“There is a real need to improve the delivery and control of insulins, and the type 1 diabetes community is looking forward to smaller devices that can help them maintain glucose control safely and conveniently," said Jonathan Rosen, JDRF Associate Director of Research. "JDRF supported the early development of AT278 as we believe that ultra-concentrated rapid acting insulins will improve the overall quality of life for people living with type 1 diabetes and we look forward to the results of this Phase I clinical trial."
The double-blind, randomised, two-way cross over Phase I clinical study in Type I diabetic patients will compare the pharmacokinetic and pharmacodynamic profiles of AT278 to a current rapid acting insulin treatment. The trial is being conducted in Austria at an internationally recognised centre of excellence in the field of diabetes research and preliminary results are anticipated in H2 2021.
Article sourced from: https://arecor.com/wp-content/uploads/2020/12/Arecor-First-Patient-Dosing-In-AT278-Phase-I-Clinical-Trial-14Dec20.pdf
Published on: 14.12.20