Austin-based Xeris Pharmaceuticals announced that is set to dose the first patient with a soluble glucagon for patients with type 1 diabetes in the company’s current phase II clinical study, led by the Baylor College of Medicine researcher Dr. Morey Haymond, as part of a new US Investigational New Drug (IND) application.
The injection is called Xeris’ G-Pen Mini and is a room-temperature stable glucagon product, which the pharmaceutical company expects to be an effective and convenient treatment for mild-to-moderate hypoglycemia or low blood sugar.
Glucagon is already used on diabetes, but is now only approved in glucagon emergency kits (GEKs), developed by Eli Lilly Company and Novo Nordisk for the treatment of severe hypoglycemia.
Currently, the drug is only available in the form of dry powder, and the patients have to reconstitute it using a water-filled syringe, which is a multi-step lasting process. By creating the injection, Xeris aims to introduce a faster and more patient-friendly tool.
“We are pleased to announce the start of this Phase 2 clinical study under the direction of Principal Investigator, Morey Haymond, MD at the Baylor College of Medicine in Houston, Texas” said Douglas R. Baum, Xeris’ CEO.
Mr. Baum went on to state that ”G-Pen Mini (glucagon injection) is the third Xeris glucagon product to begin Phase 2 testing. We successfully completed a Phase 2 trial with our first glucagon product, the G- Pen (glucagon injection) for treatment of severe hypoglycemia, and recently announced the initiation of our pumpable glucagon program. We plan to investigate the use of our soluble glucagon in a number of new applications in diabetes and in other conditions where hypoglycemia is prevalent.”
On this phase of the clinical trial, researchers will perform a single center, blinded, randomized, 3-way crossover dose ranging study which includes adults with type 1 diabetes. In this way, the safety, tolerability and efficacy (through pharmacokinetics and pharmacodynamics) of the G-Pen Mini as a treatment of mild-to-moderate hypoglycemia, a result of insulin treatment, will be analyzed.
The glucagon injection is thought to be a stable, ready-to-inject liquid that can be packaged and delivered, including in devices such as auto-injectors, pumps, and multi-dose pens.
“Our team is excited to partner with Xeris and utilize mini dosing of their stable glucagon to treat mild to moderate hypoglycemia. Having established the concept and the utility of mini dosing glucagon, the use of Xeris’ non-aqueous mini-dose glucagon has many advantages,” said Dr. Haymond.
The researcher added that the G-Pen Mini “does not require mixing, uses subcutaneous injection, and is thus ready to use, making it far more convenient and acceptable for patients treating mild to moderate hypoglycemia,” since, for him ”in many cases it is difficult or problematic for diabetic patients to consume carbohydrate-based calories when their blood glucose is low or dropping to dangerous levels. Therefore an additional advantage of glucagon mini-dosing is potentially avoiding more severe hypoglycemic events.”