AT247 – Ultra-Rapid Acting Insulin (URI)

AT247 is a novel meal-time insulin formulation which significantly accelerates insulin absorption post injection to enable more effective management of blood glucose levels. It has pharmacokinetic and pharmacodynamic properties that more closely match the physiological insulin secretion profile of a healthy individual without diabetes, significantly improving blood glucose control and flexibility of insulin dosing as well as the clinical benefits of reducing both hypo and hyperglycaemia.

AT247 is under development at Arecor as the best in class URI for patients with Type 1 and Type 2 diabetes mellitus (DM) who self-administer insulin via multiple daily injection or continuous infusion (pump therapy) and is compatible with all delivery formats.

 

What is Diabetes?

 

What is hypoglycaemia and hyperglycemia?

The Medical Need

There is an urgent need for a more rapid acting insulin analogues to deliver improved patient outcomes. By combining both accelerated absorption and faster onset of action of insulin post injection, the following clinical benefits and improved patient healthcare outcomes are possible:

  • Improved post prandial glucose (PPG) control enables the patient to closely manage and control their blood glucose after eating a meal leading to improved long-term outcomes.
  • More Time In Range (TIR) is defined as the % of time spent in the target blood glucose range. More time spent out of range, either too high (hyperglycaemia) or too low (hypoglycaemia) results in long term health complications such as cardiovascular disease, kidney and eye damage. Improving PPG and TIR, particularly around difficult to control meal-times, will result in improved clinical health outcomes, quality of life and reduce mortality.
  • Ultra-rapid acting products allow greater flexibility around the timing of dosing insulin rather than specific time before eating. The combined fast absorption and early onset of action of AT247 provides greater control and flexibility for patients.
  • Ideal insulin for pump therapy (continuous insulin infusion). Systemic exposure and clearance of current rapid insulins is not fast enough to support closed loop artificial pancreas (AP) delivery systems without risking significant dose stacking and life threating hypoglycaemia. AP systems monitor patient glucose levels continuously by a continuous glucose monitor and from these readings the correct insulin dose is automatically administered to the patient via a wearable insulin pump, at any given time, 24 hours a day. Faster acting insulins such as AT247 to enable a true artificial pancreas. ‘Closing the loop’ remains the panacea for insulin delivery and treatment. In addition, due to its superior PK/PD profile, AT247 may allow insulin pump users to eat larger amount of carbohydrates without the need to switch to manual mode which is particularly important for children and adolescents.

The Market

Diabetes is a large and growing market:

  • Currently there are ~ 463m people with diabetes, with ~26m insulin users and a $22bn global insulin market¹
  • By 2040 there will be an estimated 700m diabetics¹

Whilst there are rapid acting insulins available on the market, there remains a significant need for faster acting insulins as diabetes care advances towards more personalised treatment regimes and sophisticated drug/device combinations such as the automated Artificial Pancreas system. This is the holy grail for diabetes treatment removing the burden of self-management altogether

By developing novel superior formulations of existing therapeutic products, these enhanced therapeutics can be brought to market quickly, at relatively low cost and risk, whilst delivering significant clinical benefits to patients

¹International Diabetes Federation, Diabetes Atlas, 2019