Xeris Starts Phase 2 Trial on Stabilized Glucagon, Awarded NIH Grant for Glucagon Mini Dose Pen
Xeris announced last month the beginning of its phase 2 trial of a room temperature stabilized glucagon. The trial will compare Xeris’ glucagon to Eli Lilly’s glucagon emergency kit, which is the current way patients deal with severe hypoglycemia (or a similar kit by Novo Nordisk). Xeris’ glucagon formulation would not require mixing prior to use, meaning it would be “ready to inject.” That itself would be a major advantage. The company plans to use the new glucagon in an auto-injector pen (called the G-Pen) for severe hypoglycemia (similar to an EpiPen for allergies), which the company says could be available by 2015.
Xeris was also recently awarded a government grant to develop a glucagon mini-dose pen (G-Pen Mini) for mild to moderate hypoglycemia (e.g., a blood glucose of 50 mg/dl). Now this in our view would be really exciting. The company is on track to move the product into a phase 2 study in early 2014, with FDA approval potentially in 2016. Although a mini-dosing pen will not be for everyone (some might prefer to use glucose tablets, food, juice, etc.), if the development goes as planned, it will allow patients to take mini doses of glucagon to accurately correct moderately low blood sugars. Without having to correct a low blood glucose by eating, this could help many patients avoid the roller coaster pattern of over-treating lows. (As Dr. Jeremy Pettus of UCSD says, once he starts walking to the refrigerator, “it’s all over!”) Ideally, the G-Pen Mini would also help prevent the weight gain associated with eating or drinking too many calories while attempting to correct hypoglycemia. Time will tell, once the results are in.
Along with the G-Pen and G-Pen Mini, Xeris is working on a pump formulation (G-Pump) of glucagon for use in a bi-hormonal artificial/bionic pancreas. Out of several companies, Xeris appears to be the furthest along in bringing such a glucagon product to market. There are major questions associated with what FDA will require in terms of data, what the dosing and cost would be, and more. We’ll continue to watch this field closely. –NL/AB