Progress of Phase I clinical study of AT278

Arecor provides update on progress of second Phase I clinical study of ultra-rapid, ultra-concentrated insulin candidate AT278

Cambridge, UK, 2 October 2023: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today's therapies to enable healthier lives, today announces that, in line with the update provided within its Interim Results on 14 September, the Group has taken the decision to increase the number of subjects within its ongoing Phase I clinical trial of ultra-rapid, ultra-concentrated insulin candidate AT278.

The increase in the number of subjects within the study, from 32 to 42, will increase the power of the study and, in turn, increase the value of the results for patients with high insulin needs. Results are expected in early 2024.

Sarah Howell, Chief Executive Officer at Arecor, said: "Having already demonstrated AT278's very promising profile in Type 1 diabetic patients, this is a key clinical study for AT278 in the Type 2 patient population. The number of people living with Type 2 diabetes is increasing, year-on-year, driven by the obesity epidemic, and many patients are becoming insulin resistant, requiring large volumes of insulin and multiple injections to manage their condition, which is a heavy daily burden. AT278 has the potential to be the first, and potentially only, highly concentrated and very rapid acting insulin and thereby become the gold standard insulin for those with high daily insulin needs. AT278 also has the potential to be a critical enabler in the development of next generation miniaturised and longer wear insulin delivery systems. And with all three major insulin device companies having access to patch pump technology, we expect an acceleration in the development of these next generation systems, which require a concentrated rapid acting insulin."

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 42 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.