Therapy demonstrates significantly accelerated insulin absorption and early exposure.
Arecor has announced headline results from the second phase 1 clinical trial of its ultra-rapid acting insulin, AT247, which supports the facilitation of a fully closed loop artificial pancreas.
AT247 is an ultra-rapid-acting novel formulation of insulin that has been designed to accelerate the absorption of insulin post-injection. The superior pharmacokinetics (PK) and pharmacodynamics (PD) profile of a single AT247 dose, compared with gold standard insulins NovoLog and Fiasp, has been previously demonstrated in a phase 1 study.
This second clinical study further confirms that AT247 has a superior PK profile compared with NovoLog and Fiasp – showing a statistically significant difference when meeting the trial’s co-primary endpoint.
AT247 also demonstrated a statistically superior early glucose-lowering effect in the trial’s second primary endpoint compared with NovoLog. The trial further demonstrated that AT247 can be safely and effectively delivered via continuous SC infusion using an insulin pump.
With a superior PK profile and promising PD results, this study supports the potential that AT247 can enable even more effective disease management for people with type 1 diabetes using fully automated delivery of insulin via a pump in closed loop mode.
Dr Victoria Mirza, the principal investigator for the clinical trial, explained: “AT247 has clearly demonstrated faster insulin absorption when delivered by continuous infusion via an insulin pump. With its PK profile, AT247 has the potential to significantly improve blood glucose control when delivered via insulin pump and be an important next step in enabling the development of a fully closed loop/artificial pancreas system for people living with diabetes.”
Sarah Howell, chief executive officer of Arecor, reflected: “These results show, once again, that AT247 has a stronger overall profile than the rapid-acting insulins currently available to patients and they reinforce our belief in its potential to facilitate a fully closed loop artificial pancreas, a potentially life-changing treatment option for people living with diabetes.”
“The successful completion of this trial, the first to investigate the potential of AT247 when delivered by subcutaneous infusion via an insulin pump over a period of three days, is an important milestone for Arecor. This study further demonstrates the superior pharmacokinetic profile of AT247 with accelerated insulin absorption and exposure compared to two gold-standard insulins available today,” she added.
Detailed data from the trial will be submitted for presentation at a future international diabetes conference.