JDRF, the leading global organization focused on type 1 diabetes (T1D) research, has partnered with Arecor Ltd, a UK-based leading formulation technology company focused on delivering superior biopharmaceuticals via the innovative reformulation of proteins and peptides, to advance the pre-clinical trials of its ultra-concentrated insulin.
The goal of the partnership is to accelerate the development of a stable, rapid-acting, ultra-concentrated insulin of up to 1,000 U/mL, which will not only offer a vastly superior mealtime insulin product for people requiring >200 U/day, but is also a critical step towards the advancement of the miniaturization of delivery devices, including next-generation artificial pancreas systems for people with type 1 diabetes.
Arecor and JDRF will work closely together on the project, and JDRF will provide Arecor with up to $900,000 in milestone funding over 12 months to complete product development to the end of pre-clinical pharmacokinetic/pharmacodynamic modelling (PK/PD).
Next-generation device technology such as wearable, continuous administration patch pumps and implants are critical future developments for people living with diabetes, improving glycemic control and compliance, thus reducing adverse states such as hypoglycaemia and diabetic ketoacidosis (DKA), as well as overall complications and mortality. Currently available prandial insulins are available at concentrations of up to 200 U/mL. The development of acceptable formulations of these insulins at concentrations of up to 1,000 U/mL will reduce the dosing volume by 5- to 10-fold, and thus enable the miniaturization of the delivery devices.
Increasing insulin concentration is a significant formulation challenge both from an in-vitro and in-vivo perspective. In-vitro, it leads to an increase in viscosity and impairment of stability. In-vivo, increasing the concentration of insulin delays the onset of action. Arecor is applying its proven formulation expertise and proprietary platform technology to overcome the in-vitro and in-vivo challenges to optimize an ultra-concentrated insulin with a PK/PD profile similar to current rapid-acting insulin analogs.
Sarah Howell, CEO of Arecor, said, "We are delighted to be partnering with the JDRF as a leading global organization in type 1 diabetes research. This partnership will accelerate the development of Arecor's reformulated, ultra-concentrated, rapid-acting insulin program, which is a critical unmet need in the drive towards new miniaturized insulin-delivery technology. Ultra-concentrated insulin is an important product component in our portfolio of next-generation diabetes products."
"We are delighted to partner and collaborate with Arecor. There is a real need to improve the delivery and control of insulins, and the type 1 diabetes community is looking forward to smaller devices that can help them maintain glucose control safely and conveniently," said Vincent Crabtree, director of research business development at JDRF. "JDRF is supporting ultra-concentrated insulins that we believe will improve the overall quality of life for people living with type 1 diabetes."