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AT278 – Ultra-Concentrated Ultra-Rapid Acting Insulin
- Designed to accelerate the absorption of insulin post injection, even when delivered at a high concentration, and hence via a lower injection volume
- Potential to enable more effective management of blood glucose levels for the increasing number of people with diabetes with high daily insulin requirements whilst maintaining the convenience and compliance benefits of delivering high insulin doses in a lower injection volume via a single injection
- A truly rapid acting concentrated insulin is a critical step towards the advancement and miniaturisation of the next generation of insulin delivery devices
- Exceeded expectations in a positive Phase I clinical trial, demonstrating a significantly accelerated early pharmacokinetic (PK)/ pharmacodynamic (PD) profile compared to the same dose of lower concentration, gold standard rapid acting insulin, NovoRapid®
- A second Phase I trial was initiated in January 2023 in Type 2 diabetic patients, to further explore the product’s potential
AT278 – Ultra-Concentrated Ultra-Rapid Acting Insulin
AT278 is an ultra-concentrated novel formulation of ultra-rapid acting 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. AT278 has the potential to enable more effective management of blood glucose levels to the increasing number of people with diabetes with high daily insulin requirements (>200 units/day) whilst maintaining the convenience and compliance benefits of being able to deliver these high insulin doses in a lower injection volume via a single injection. In addition, a truly rapid acting concentrated insulin is also a critical step towards the advancement and miniaturisation of the next generation of insulin delivery devices.
AT278 has demonstrated excellent clinical results so far, meeting all of its primary and secondary endpoints with positive results in a Phase I clinical trial in patients with Type I diabetes.
AT278 is also currently being investigated in a second Phase I trial in patients with Type 2 diabetes, to further explore the product’s potential to disrupt the market as the first concentrated, yet rapid acting, insulin. The study, initiated in January 2023, is expected to complete within Q4 2023.
The Medical Need
There is a high unmet need for a stable, rapid-acting, ultra-concentrated insulin of up to 1000 U/mL, that can enable more effective disease management for those people with diabetes requiring >200 U/day.
An ultra-concentrated product is key for the miniaturisation of insulin delivery devices. Next-generation device technology such as wearable, continuous administration patch pumps and implants, are critical for future developments for people living with diabetes. In particular, these devices offer the potential to improve compliance in difficult to treat groups such as children and teenagers. Such delivery systems when combined with a rapid acting insulin could improve glycaemic control and compliance, thereby reducing adverse events, as well as overall complications and morbidity.
As yet, there are no concentrated (>200U/mL) rapid acting insulin products on the market.
The Market
Diabetes has reached pandemic level worldwide. With 1 in 10 adults living with diabetes there is a heavy health and financial burden on every nation in the world.
- Currently there are ~ 537m adults living with diabetes worldwide, and that number is expected to rise to 643 million by 2030 and 783 million by 2045.
- Within this, there are ~56m daily insulin users, creating a $22bn global insulin market
Even with the gold standard insulins available to patients today, there is still a need for faster acting insulins as diabetes care advances towards enhanced monitoring and tighter glucose controls. This combined with the rise in innovative delivery devices, allied with technologies where a fast and predictable onset of action is essential, offers Arecor’s novel superior insulin formulations the opportunity to pave the way towards the advancement and miniaturisation of the next generation of insulin delivery devices and change the paradigm of diabetes treatment.