BioChaperone Glucagon, an aqueous formulation stable ready-to-use glucagon human, could be used as emergency treatment of severe hypoglycemia and in the context of an artificial pancreas, bihormonal
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The study will document the safety and tolerance of BioChaperone Glucagon, as well as its profiles, pharmacokinetics and pharmacodynamics in people with type 1 diabetes
Results expected in Q4 2017
Lyon, France, June 1, 2017 – 7: 30 am CET – Adocia (Euronext Paris : FR0011184241 – ADOC), a biopharmaceutical company specializing in the treatment of diabetes with innovative formulations of proteins approved, today announced the initiation of a Phase 1 clinical trial of BioChaperone® Glucagon, its aqueous formulation of glucagon human. The proprietary technology BioChaperone® allows for the solubilization and stabilization of glucagon human at neutral pH. A liquid formulation of glucagon in human could be used as a treatment injectable ready-to-use for severe hypoglycemia and in the context of an artificial pancreas, bihormonal (PABH), that is to say, an automated pump that can deliver both insulin and glucagon in response to blood glucose level of the person measured in real-time.
This study aims to compare the safety and tolerance of BioChaperone Glucagon (BC Glucagon) of a glucagon human available on the market (lyophilized powder for reconstitution immediately before injection, GlucaGen® HypoKit®, Novo Nordisk). The study will evaluate two fixed-dose different representative of two potential applications distinct, namely the emergency treatment of severe hypoglycemia and the frequent administration of micro-bolus in a PABH.
“We are excited to initiate the clinical evaluation of BioChaperone Glucagon, the only aqueous formulation of stable glucagon human development.” commented Olivier Soula, deputy General Manager and R&D Director of Adocia. “On the basis of positive results of stability, our formulation could address the need for medical emergency treatment ready-to-use hypoglycemia and use in the artificial pancreas. This study will inform, by the end of the year, the clinical performance of our product for these two indications. ”
Hypoglycemia is a significant risk and ever-present for people with diabetes who use insulin. Glucagon human is the only product approved for the emergency treatment of severe hypoglycemia. The commercial kits currently available consist of the glucagon human freeze-dried to be reconstituted immediately prior to injection (two brands available : GlucaGen HypoKit, Novo Nordisk and Glucagon, Eli Lilly). However, as demonstrated in several clinical studies, their use is made difficult by the many steps required for reconstitution and injection. Therefore, there is a medical need for an solution in auto-injector ready to use to facilitate the injection and to ensure administration of the correct dose in cases of extreme urgency.
The aqueous formulation of glucagon in human Adocia should allow to address the medical need for emergency treatment, ready-to-use, severe hypoglycemia, and to make possible the chronic use of glucagon in a PABH. The formulation strategy of Adocia takes advantage of the established results in terms of safety and efficacy of the glucagon human. In particular, the technology BioChaperone allows for the solubilization and stabilization of glucagon in human aqueous solution at physiological pH, thus avoiding the use of organic solvents or the modification of the native sequence of amino acids of this peptide.
In this randomized, double-blind, cross-over three times against a comparator of 27 participants with type 1 diabetes will be submitted randomly to a sequence of three treatments : BC Glucagon formulation 1, BC Glucagon formulation 2 and the GlucaGen HypoKit. Each treatment will be administered at a fixed dose of 50 µg and 1 mg, in two subcutaneous injections, at the occasion of three separate visits. 1 mg is the standard dose for the emergency treatment of severe hypoglycemia, and 50 mcg is a dose comparable to the micro-bolus injected via a artificial pancreas system.
The main objective of this study is to evaluate the safety and tolerance of single-dose, fixed-dose, administered by subcutaneous formulations of BC Glucagon and GlucaGen HypoKit in subjects with type 1 diabetes. The secondary objectives include the comparison of the pharmacokinetic profiles and pharmacodynamics of BC Glucagon to those of GlucaGen HypoKit at two different doses.
Adocia is the sponsor of this study, which will be conducted by Profile Neuss in Germany. The results are expected in Q4 2017.
This study is registered and will appear on clinicaltrials.gov.
About ADOCIA
Adocia is a biotechnology company clinical stage specialized in the development of innovative formulations of proteins already approved. The portfolio of injectable products of Adocia for the treatment of diabetes, which includes four products in clinical phase and six products in the preclinical phase, is one of the widest and most differentiated in the industry.
The platform’s proprietary technology BioChaperone® aims to improve the effectiveness and/or safety of therapeutic proteins and facilitate their use by patients. Adocia customizes BioChaperone to each protein for a given application, in order to address needs specific to patients.
The clinical pipeline of Adocia includes four innovative formulations of insulin for the treatment of diabetes: two formulations, ultra-fast insulin analog (BioChaperone Lispro U100 and U200), a formulation of rapid-acting insulin human (HinsBet U100), and a combination of slow insulin glargine and rapid-acting insulin lispro (BioChaperone Combo). Adocia is also developing an aqueous formulation of glucagon, human (BioChaperone Human Glucagon), two combinations of insulin glargine with GLP-1 (BioChaperone Glargine Dulaglutide and BioChaperone Glargine Liraglutide), two combinations of insulin lispro with hormones prandial synergistic (BioChaperone Lispro Pramlintide and BioChaperone Lispro Exenatide) and a concentrated formulation is fast-acting insulin human (HinsBet U500), all in preclinical development.
Adocia aims to deliver “innovative medicines for everyone, everywhere.”
To learn more about Adocia, please visit us on www.adocia.com
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