The need

Glucagon is a hormone that causes increase in blood glucose by promoting breakdown of liver glycogen. Glucagon is used for emergency treatment of severe hypoglycaemia. Administration of therapeutic glucagon as a rescue treatment for severe hypoglycaemia is safe and effective, however, its use is challenging due to its low solubility and very poor stability in liquid solution. Thus, currently available glucagon treatments (rescue kits) are only available in the form of a lyophilised powder, which requires the caregiver to perform a complex multi-step reconstitution procedure prior to administration in this highly stressful emergency situation. The reconstitution procedure leads to handling errors and delayed administration of glucagon, resulting in sub-optimal treatment. This is a significant barrier to the use of these rescue kits with recent usability studies demonstrating that more than 80% of people failed to reconstitute properly and inject the recommended dose of glucagon. As a result, only 10-20% of high-risk patients own a glucagon emergency kit. In addition, a stable aqueous form of glucagon is a critical requirement for the development of bi-hormonal pump systems that enable efficient control of blood glucose by continuous delivery of insulin and glucagon at precisely controlled rates.

Product concept

Arecor’s glucagon product is based on reformulation of commercially available glucagon using the Arestat™ technology, delivering stable aqueous compositions at 1 mg/mL (ready to inject for emergency use) and 3-5 mg/mL (bi-hormonal pump application). For the pump application, the product is stable at 37°C for a minimum of 1 week during use, and has a shelf-life of at least 2 years.

Status

Arecor has developed prototype formulations of aqueous glucagon that show sufficient stability supporting their use both as an emergency medicine and in a bi-hormonal pump application at neutral pH. The resultant product formulations have very low viscosity and withstand physical stress associated with pump and syringe delivery. The product is currently in pre-clinical development.

Arecor’s proprietary stable and ready-to-inject liquid glucagon has the potential to significantly de-risk and simplify the administration of this life-saving treatment as well as enable the development of a bi-hormonal pump system. This will reduce a major source of anxiety for insulin users worldwide (currently ~25million).