Arecor Limited, a leader in developing superior biopharmaceuticals through the application of an innovative formulation technology platform, and JDRF, the leading global organisation funding type 1 diabetes research, are pleased to announce the successful completion of their partnered programme and the pre-clinical development of an ultra-concentrated, rapid-acting insulin product (“the product”) for the significantly enhanced treatment of insulin-requiring diabetes, particularly type 1 diabetes.

The product, which is scheduled to progress into a first-in-human clinical study in people with type 1 diabetes in 2018, is a significant step toward enabling miniaturization of next-generation insulin delivery technologies that are promising to transform the life of people with diabetes. The product will also offer superior treatment and quality of life for people requiring large doses of insulin to manage their condition.

More specifically, the product will significantly improve the treatment of patients requiring more than 200 Units of insulin per day. Development of an ultra-concentrated insulin product, capable of delivering up to 1,000 Units/mL, was hitherto a considerable scientific challenge, but is one that has now been successfully addressed during the development programme, by applying Arecor’s proprietary formulation technology, ArestatTM, to existing off-patent rapid acting insulin analogues at concentrations of up to 1,000 Units/mL.

The product has been shown to demonstrate a similar rapid onset of action, in comparison to the currently marketed low-concentration analogues. The product has also demonstrated excellent stability, which is always a pre-requisite for any commercially viable product. Indeed, during the programme, a number of considerable challenges associated with increasing insulin concentration, such as poor stability and the slow onset of insulin action, have been overcome using the ArestatTM technology. The technology has furthermore delivered excellent rapid pharmacokinetic and pharmacodynamic profiles in validated animal models, in comparison to currently marketed, competitor rapid-acting products.

Sanjoy Dutta, JDRF commented:

“We are pleased at the progress being delivered as a result of JDRF’s partnership with Arecor, as we seek to improve the delivery and control of insulin,” said Sanjoy Dutta, JDRF Assistant Vice President, Research. “People with type 1 diabetes are looking forward to smaller devices that can help them maintain glucose control safely and conveniently. Achieving miniaturized technologies, and therefore an improved quality of life, will require ultra-concentrated insulins such as the one being developed through this research.”

Arecor’s CEO, Sarah Howell, commented:

“The successful development of the ultra-concentrated rapid acting insulin is a very important milestone in Arecor’s mission to develop superior proprietary products that will significantly improve the treatment options and ultimately the quality of life of people living with diabetes. Having already succeeded in developing a pre-clinical proof-of-concept insulin with ultra-fast onset, the ultra-concentrated rapid acting insulin is another key product within our diabetes portfolio. The support from JDRF has been invaluable and we look forward to continuing to build this fruitful partnership to deliver our shared common future objectives – namely to deliver substantially improved treatment options for people living with diabetes”.