FIRST PATIENT DOSED IN SECOND PHASE I CLINICAL TRIAL OF AT278 ULTRA-CONCENTRATED, ULTRA-RAPID ACTING INSULIN CANDIDATE

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

FIRST PATIENT DOSED IN SECOND PHASE I CLINICAL TRIAL OF AT278 ULTRA-CONCENTRATED, ULTRA-RAPID ACTING INSULIN CANDIDATE

- Disrupter insulin with potential to be the first ultra-concentrated and ultra-rapid acting insulin available for patients
- AT278 aims to significantly improve post prandial glucose control and reduce injection volume and potentially enable fewer injections per day for people with Type 2 diabetes who have high insulin needs
- Ultra-concentrated, ultra-rapid acting insulin such as AT278 is critical to development of next generation miniaturised insulin delivery devices
- Trial expected to complete in Q4 2023

Cambridge, UK, 22 March 2023: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today’s therapies to enable healthier lives, today announces that the first patient has been dosed in its Phase I clinical trial investigating AT278, an ultra-rapid acting, ultra-concentrated (500 U/mL) insulin candidate, in Type 2 diabetic patients, the primary target population.

The trial is a double blind, randomised, crossover study comparing the pharmacokinetic (PK) and pharmacodynamic (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, which is expected to complete within Q4 2023, is being conducted at the Medical University of Graz, Austria, an expert clinical research facility in metabolic diseases research and euglycaemic clamp methodology, with Professor Thomas Pieber as the trial’s Principal Investigator.

Sarah Howell, Chief Executive Officer at Arecor, said: “Having already demonstrated AT278’s very promising profile in Type 1 diabetes patients, we look forward to furthering our understanding of its potential impact in Type 2 diabetes patients, the primary target market for this potential insulin treatment.

"The number of people living with Type 2 diabetes is increasing year-on-year and driven by the obesity epidemic, many are becoming insulin resistant, requiring large volumes of insulin and multiple injections to manage their condition, which is a heavy daily burden. With no concentrated (>200 U/mL) rapid acting insulin products on the market, AT278 could be the first such product available to patients, enabling effective blood glucose management alongside the convenience and compliance benefits of high insulin doses in a lower injection volume via a single injection. In addition, a truly rapid acting, concentrated insulin is a critical step towards the advancement and miniaturisation of the next generation of insulin delivery devices.”

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

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