Arecor Therapeutics plc says the BASG (Bundesamt für Sicherheit im Gesundheitswesen) has cleared the company’s clinical trial application (CTA) for AT278, an ultra-rapid acting, ultra-concentrated (500 U/mL) insulin candidate, in type 2 diabetic patients.
The CTA approval means Arecor can start its second phase I clinical trial for AT278. AT278 has previously demonstrated a faster insulin absorption with an accelerated pharmacokinetic (PK) and pharmacodynamic (PD) profile compared to the lower concentration NovoRapid (100 U/mL) in a phase I clinical study in Type 1 diabetic patients. This type 2 diabetes trial will also focus on exploring the PK/PD profile of AT278 compared with NovoRapid (100 U/mL), as well as Humulin-R U500.
The company also revealed that the Japan Patent Office has granted a patent protecting novel formulations of its insulin products, AT247 and AT278. The same patent was also granted in South Korea.
Arecor’s trial details
The trial is a double blind, randomized, crossover study comparing the PK/PD profile following a single subcutaneous dose of 0.5 U/Kg of AT278 (500 U/mL) with NovoRapid (100 U/mL) in 32 people with Type 2 diabetes in a euglycemic clamp setting. In addition, the PK/PD profile following a single subcutaneous dose of 0.5 U/Kg Humulin-R U500 will be evaluated in each of the participants.
The trial will be conducted at the Medical University of Graz, Austria, a research facility in metabolic diseases research and euglycemic clamp methodology, with Thomas Pieber as the trial’s principal investigator. The trial is expected to start in 2022 and complete within Q4 2023.
Sarah Howell, chief executive officer of Arecor, said: “With regulatory approval to commence our second clinical trial for AT278, we can continue the rapid progress we are making across our proprietary diabetes focused portfolio. With its very promising profile already demonstrated in our previous study, AT278 has the potential to disrupt the market for insulin treatment as the first concentrated, yet very rapid acting insulin and to become the gold standard insulin for the growing population of people with diabetes with high daily insulin needs as well a critical enabler in the development of next generation miniaturized insulin delivery systems. With approximately 537 million people living with diabetes worldwide, of which approximately 56 million are insulin users, there has never been a greater need for improved treatment options.”
Arecor’s AT278 is an ultra-concentrated (500 U/mL) novel formulation of insulin that has been designed to accelerate the absorption of insulin post injection, even when delivered at a high concentration, and hence via a lower injection volume. Currently, there are no concentrated (>200 U/mL) rapid acting insulin products on the market, and therefore, AT278 has the potential to be the first such product available to patients.
It has the potential to enable more effective management of blood glucose levels to the increasing number of people with diabetes with high daily insulin requirements (>200 units/day) whilst maintaining the convenience and compliance benefits of being able to deliver these high insulin doses in a lower injection volume via a single injection. In addition, a rapid acting concentrated insulin is also a critical step towards the advancement and miniaturization of the next generation of insulin delivery devices.