The Chicago-based company expects to report top-line data from the study in the second half of 2019.
The trial is slated to assess Xeris’ room-temperature stable liquid glucagon as a pre-treatment to prevent exercise-induced hypoglycemia in 48 people with Type 1 diabetes who receive daily insulin treatment via a subcutaneous pump.
“Many individuals with diabetes treated with insulin experience EIH and the complexity of managing it is a major barrier to the adoption of regular physical activity. And unfortunately, today there are no approved therapies to prevent EIH. This research will help us understand the potential for ready-to-use glucagon to offer real-world benefit in reducing or preventing these challenging events during exercise,” principal investigator Dr. Ronnie Aronson said in prepared remarks.
Xeris touts its XeriSol and XeriJect formulation technologies as offering advantages over existing drug formulations, such as reducing injection volume and eliminating the need for reconstitution.
In October, Xeris announced that the FDA accepted a new drug application for its ready-to-use liquid glucagon rescue pen device.
The U.S. regulatory agency plans to make a decision about Xeris’ pen by June 10.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.