Adocia a clinical stage biopharmaceutical company focused on diabetes treatment with innovative formulations of approved proteins, announced top-line results of a phase 1 study of BioChaperone Glucagon, its aqueous formulation of human glucagon. The proprietary BioChaperone technology enables solubilization and stabilization of human glucagon at neutral pH. A liquid formulation of human glucagon may hold potential as a ready-to-inject treatment for severe hypoglycemia emergency rescue and as a companion agent to insulin in a dual hormone artificial pancreas.
The main objective of this study was to assess the safety and tolerability of subcutaneous single fixed doses of BioChaperone Glucagon and of GlucaGen HypoKit (Novo Nordisk lyophilized powder reconstituted immediately prior to injection) in subjects with type 1 diabetes. Secondary objectives included the comparison of the pharmacokinetic and pharmacodynamic profiles of BioChaperone Glucagon to those of GlucaGen HypoKit.
“We are very pleased to report positive topline results for the first clinical trial of BioChaperone Glucagon, the only stable aqueous formulation of human glucagon in development. Together with positive stability data, this first set of clinical data supports its further development as a ready-to-inject treatment for severe hypoglycemia.” said Dr. Stanislav Glezer, Adocia’s chief medical officer. “We are currently selecting an easy-to-use, state-of-the-art injection device for BioChaperone Glucagon, which aims to provide fast and reliable relief to patients living with diabetes and their caregivers in a situation of hypoglycemic emergency.”
Olivier Soula, Adocia’s deputy general manager – R&D Director added, “BioChaperone Glucagon shows that BioChaperone formulation technology enables ready-to-inject products out of unstable proteins that required to be lyophilized, while preserving clinical efficacy. We intend to leverage this unique property of BioChaperone to other potential candidates across multiple therapeutic areas.”
In this study of BioChaperone Glucagon, people with type 1 diabetes received continuous intravenous insulin infusion under medically supervised conditions to induce plasma glucose level in the range 56 to 60 mg/dL (hypoglycemic state).
Following a single subcutaneous injection of a 1 mg dose, BioChaperone Glucagon was found to have an acceptable safety and tolerability profile. In both groups, the most frequent adverse event was nausea, with 8 observed events in 25 patients for BioChaperone Glucagon vs. 5 events in 24 patients with Glucagen HypoKit.
Median time to reach a clinically safe blood glucose level of 70 mg/dL was 11 min for BioChaperone Glucagon and approximately 7 min for the commercial Glucagen drug product, with all subjects achieving resolution of hypoglycemia at the 35 minutes timepoint.