Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical company advancing today’s therapies to enable healthier lives, today presents positive results from the Phase I clinical trial of its ultra-rapid acting, ultra-concentrated insulin product candidate, AT278, at the 15th International Advanced Technologies and Treatments for Diabetes (ATTD) meeting. The abstract is available on the ATTD website.
Dr Eva Svehlikova, Investigator for the ARE-278-102 study, said: “Currently, there are no concentrated (>200U/mL) rapid acting insulin products on the market. AT278’s faster insulin absorption with an accelerated pharmacokinetic (PK) and pharmacodynamic (PD) profile when compared to NovoRapid®, the current gold standard treatment, offers the potential to significantly improve post prandial glucose control and reduce the number of daily injections for people with diabetes that have high insulin needs. These results are clinically significant and suggest that AT278 has the potential to be the first ultra-concentrated, ultra-rapid insulin available to diabetic patients.”
Sarah Howell, Chief Executive Officer of Arecor, added: “Presenting the positive data achieved in our successful AT278 Phase I clinical study at ATTD marks another significant step forward for Arecor’s best-in-class diabetes franchise. AT278, has the potential to become the gold standard insulin treatment for the growing population of people living with diabetes, who have high daily insulin needs, particularly those with type 2 diabetes. AT278 has the potential to disrupt the market, as the first ultra-concentrated (500U/mL) ultra-rapid acting insulin, reducing the burden of managing this complex disease by enabling reduced injection volumes and fewer injections per day whilst offering the potential for improved blood glucose control with its superior PK/PD profile. This combination has the potential to liberate patients with fewer injections, deliver better health outcomes and reduce the healthcare burden across the growing diabetes market. AT278 also has the potential to enable the development of next generation miniaturised insulin delivery devices, where the size of such devices is often a barrier to use by patients.”
AT278 is an investigational meal-time, concentrated (500 U/mL) novel formulation of insulin, that aims to significantly accelerate the absorption of insulin post injection, to enable more effective management of blood glucose levels. It has been designed to achieve PK/PD properties that are superior to existing rapid acting insulins, despite a 5-fold increase in concentration, thus enabling a lower volume and/or a reduced number of daily injections and offering a significant advancement in treatment for people living with diabetes who require high daily insulin doses to effectively manage their blood glucose.
The double-blind, randomised, single dose, two-period cross over Phase I clinical study (EudraCT:2020-002033-15) compared the PK/PD profiles of AT278 to NovoRapid® in 38 patients with type 1 diabetes. The trial was conducted in a glucose clamp setting at the Medical University of Graz and Joanneum Research in Austria, an internationally recognised centre of excellence in the field of diabetes research.
The PK/PD profile for AT278 was accelerated compared with NovoRapid®. Following dosing, AT278 showed a faster onset of insulin exposure compared with NovoRapid®, as demonstrated by an earlier onset of appearance (-6.0 min, P<0.0001), earlier tEarly50%Cmax (-23.0 min, P<0.0001) and 4.0 times higher AUCInsulin,0-30min (95% CI: 3.29; 4.90). AT278 also showed a more rapid onset of glucose-lowering effect compared with NovoRapid® as demonstrated by an earlier onset of action (-9.5 min, P<0.0001) and earlier tEarly50%GIRmax (-20.0 min, P<0.0001).
Overall insulin exposure and glucose-lowering effect were comparable between both insulins (AUCInsulin,0-8h treatment ratio 0.98 [95% CI: 0.92; 1.00]; AUCGIR,0-8h treatment ratio 1.02 [95% CI: 0.95; 1.09]). All reported adverse events were mild in intensity and no safety signals were detected.
The next step on the accelerated development pathway for AT278 will be to explore its potential to improve blood glucose control in people with type 2 diabetes with high daily insulin needs. With no highly concentrated (500 U/mL) rapid acting insulin products currently available, AT278 has the potential to be the first such product for this patient group to address a significant unmet need and enable better blood glucose control at meal-times.
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR)