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Type 1

Xeris Doses First Patient in Phase 2 Study of Mini-dose Glucagon for mild-moderate hypoglycemia in T1D patients

On June 5, Xeris Pharmaceuticals announced that the first patient had been dosed in its phase 2 clinical trial, which is testing “mini-dose” glucagon for the treatment of mild to moderate hypoglycemia (e.g., a glucose of 60 mg/dl). The 18-patient study is expected to wrap up by the end of the summer/early fall, which would pave the way for Xeris to conduct a larger study. For those unfamiliar, the concept of a “glucagon mini-dose” allows patients to precisely administer small amounts of glucagon to correct low blood sugars without needing to eat or drink excess carbs. This could help avoid the rollercoaster pattern of over-treating hypoglycemia with too much food and perhaps even prevent some of the weight gain associated with taking insulin. Xeris plans to make a portable pen for its mini-dose glucagon, much like how current insulin pens work. Based on the most recent timeline, Xeris’ mini-dose glucagon could be on the US market as soon as 2016. We think many patients would like this. While some, clearly, have a candy bar (or other favorite food) to treat low blood sugar, many of us know the feeling of having had enough sugar but not being able to stop eating! This would be an excellent alternative to many though of course it won’t be appropriate for all.

Currently, of course, glucagon is only approved in the form of one-time use “emergency kits” for severe hypoglycemia (i.e., when a patient is unconscious or not responding) – these kits from Novo Nordisk and Lilly require mixing dry powder with water, a process known as reconstitution. Xeris has figured out a way to stabilize the glucagon molecule, allowing it be packaged in a ready-to-inject liquid form. Several other companies, including Biodel, Locemia, Latitude, and Zealand, are also in the process of developing and testing improved glucagon therapies. Locemia is the furthest along, as the company is currently testing its intranasal glucagon for severe hypoglycemia in phase 3 trials in children and adults. –AJW/AB