Biodel, Latitude, and Xeris Seek to Improve Glucagon
By Adam Brown
At the ADA meeting. Biodel, Latitude, and Xeris had notable announcements on their glucagon programs. First, Biodel demonstrated a prototype of its new glucagon rescue delivery device. As background, current forms of glucagon require mixing a powder with water before injection (“reconstitution”). The process is rather clunky and involves several steps, a significant roadblock for untrained individuals, especially in emergency situations. Biodel’s prototype has three steps: 1) remove a cover and twist (this step mixes the glucagon and unlocks the front needle cover); 2) remove a needle shield; and 3) push the plunger to give the dose. It’s nice to see that the needle automatically retracts, and it will come in both adult and child doses. Though Biodel’s device is much simpler to use than a glucagon kit, it’s still not quite as simple as an EpiPen. Still, the company is seeking feedback from the diabetes community to further improve its prototype, and we think it is moving in the right direction. Biodel plans to submit the device for FDA approval in 2015.
Xeris and Latitude also had news at ADA, as both companies announced a partnership with JDRF to develop stable liquid glucagon formulations. Like insulin, these products will come in a liquid form – they will not require powder and water to be mixed. This would enable a very simple EpiPen-like device for treating severe hypoglycemia quickly and without the burden of the current glucagon kits. Their formulation has shown an encouraging 12 months of stability at room temperature with only 8% of drug loss (a big challenge in stabilizing glucagon). The company plans to incorporate it into a G-Pen, a two-step auto injector like the EpiPen that will deliver a 200 ul injection. Encouragingly, Xeris has received a NIDDK grant to run a clinical study of the new glucagon formulation in people with type 1 diabetes. Xeris is also in the process of developing a mini-dose pen that can be used to treat mild to moderate hypoglycemia (e.g., 50 mg/dl). On that front, the Helmsley Charitable Trust has also given the company a grant to run a clinical trial. It will be directed by Dr. Morey Haymond, who first published the now widely accepted mini-dosing algorithm. While many patients might prefer to eat rather than take a mini-dose of glucagon, we think some might be fans of the precision of mini-dosing and the very quick action profile of glucagon relative to many foods.
A stable liquid glucagon will be an important part of a bihormonal artificial pancreas, such as those being developed by Drs. Edward Damiano and Steven Russell and by Dr. Kenneth Ward’s group. Given the very strong results Dr. Damiano has shown using both insulin and glucagon in his studies (virtually no hypoglycemia and an average blood glucose of about 130-140 mg/dl based on preliminary results from his five-day, outpatient Beacon Hill study), we think this strategy holds lots of promise. –MN/AB
