Arecor Therapeutics plc
(“Arecor”, the “Company” or the “Group”)

ARECOR ANNOUNCES PUBLICATION OF PHASE I DATA FOR AT278 IN DIABETES CARE

- Ultra-concentrated, ultra-rapid acting insulin AT278, a promising candidate in the pursuit of next generation insulins to simplify and improve glycemic control

Cambridge, UK, 30 January 2023: Arecor Therapeutics plc, a globally focused biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces that the American Diabetes Association journal, Diabetes Care, has published data from the Company’s Phase I clinical trial of AT278, its ultra-concentrated (500 U/mL), ultra-rapid acting insulin product candidate.

The manuscript, titled ‘Pharmacokinetics and Pharmacodynamics of a Novel U500 Insulin Aspart Formulation: A Randomized, Double-Blind, Crossover Study in People with Type 1 Diabetes’, is now available online.

In the Phase I clinical study in people with Type I diabetes, AT278 (500 U/mL) clearly demonstrated faster insulin absorption with an accelerated pharmacokinetic (PK) and pharmacodynamic (PD) profile compared to gold-standard insulin NovoRapid® (100 U/mL) despite a 5-fold increase in concentration.

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 truly rapid acting concentrated insulin is also a critical step towards the advancement and miniaturisation of the next generation of insulin delivery devices.

Dr Eva Svehlikova, first author of the study, said: “Publication of these data in a peer-reviewed journal supports the representation of AT278 as a promising candidate in the pursuit of next generation insulin analogs designed to improve postprandial glycemic control with its superior PK/PD profile as well as reducing the injection volume and/or number of daily injections for people with diabetes who have high daily insulin needs.”

Sarah Howell, Chief Executive Officer of Arecor, said: "Publication of the AT278 clinical trial in this prestigious journal highlights the significance of this clinical data and the need for our next generation insulins to bring improved treatment options to people living with diabetes to simplify and improve their blood glucose management. As a potential market disrupter, AT278 has the potential to become the gold standard insulin for the growing population of people with diabetes with high daily insulin needs as well as a critical enabler in the development of next generation miniaturised 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.”

AT278 is also currently being investigated in a second Phase I trial in patients with Type 2 diabetes, to further explore the product’s potential to disrupt the market as the first concentrated, yet rapid acting, insulin. The study initiated earlier this month and is expected to complete within Q4 2023.