Arecor Therapeutics plc announces that the BASG (Bundesamt für Sicherheit im Gesundheitswesen) has approved the company’s clinical trial application (CTA) for AT278, an ultra-rapid-acting, ultra-concentrated (500 U/ml) insulin candidate, in patients with type 2 diabetes.
The CTA’s approval means Arecor can begin its second phase clinical trial of AT278. AT278 previously demonstrated faster insulin absorption with an accelerated pharmacokinetic (PK) and pharmacodynamic (PD) profile compared to a lower concentration of NovoRapid (100 U/mL) in a phase I clinical trial in patients with type 1 diabetes. This type 2 diabetes trial will also focus on studying the PK/PD profile of AT278 compared to NovoRapid (100 U/mL) as well as Humulin-R U500.
The company also revealed that the Japan Patent Office has issued a patent protecting new formulations of AT247 and AT278 insulin products. The same patent was issued in South Korea.
The trial is a double-blind, randomized, crossover study comparing the PK/PD profile of a single subcutaneous dose of 0.5 U/kg AT278 (500 U/ml) with NovoRapid (100 U/ml) in 32 subjects with type 2 diabetes . under euglycemic clamp conditions. In addition, the PK/PD profile following a single subcutaneous dose of 0.5 U/kg Humulin-R U500 will be evaluated in each participant.
The trial will be conducted at the Medical University of Graz, Austria, Research Center for Metabolic Diseases and Euglycemic Clamp Methodology, with Thomas Pieber as principal investigator. The trial is expected to begin in 2022 and conclude in the 4th quarter of 2023.
Sarah Howell, chief executive officer of Arecor, said: “With regulatory approval to start our second AT278 clinical trial, we are able to continue the rapid progress we are making in our diabetes mellitus targeted portfolio. With its highly promising profile already demonstrated in our previous study, AT278 has the potential to disrupt the insulin treatment market as the first concentrated but very fast-acting insulin and become the gold standard insulin for the growing population of people with diabetes with high daily insulin requirements, as well as an important factor in the development of miniaturized next-generation insulin delivery systems. With an estimated 537 million people living with diabetes worldwide, of whom approximately 56 million use insulin, there has never been a greater need for improved treatment options.”
AT278 is an ultra-concentrated (500 U/ml) new insulin formulation that has been designed to accelerate post-injection insulin absorption, even when administered at a high concentration and thus through a smaller injection volume. There are currently no concentrated (>200 U/mL) rapid-acting insulin products on the market, and therefore AT278 may be the first such product available to patients.
It has the potential to more effectively manage blood glucose levels for the growing number of people with diabetes with high daily insulin requirements (>200 units per day), while retaining the convenience and compliance benefits of delivering high doses of insulin in a smaller volume of insulin. injections in one injection. In addition, rapid-acting concentrated insulin is also a critical step towards the development and miniaturization of the next generation of insulin delivery devices.
https://www.labiotech.eu/trends-news/arecor-second-type-2-diabetes-clinical-trial/ Arecor to start second clinical trial for type 2 diabetes