Lyon, France, June 7, 2017 – 18 pm CEST – Adocia (Euronext Paris: FR0011184241 – ADOC), a biopharmaceutical company specializing in the treatment of diabetes through innovative formulations of proteins approved, today announced the launch of a clinical study of Phase 1b of assessing the linearity of the response to the dose of BioChaperone® Combo 75/25 at three different doses in people with type 2 diabetes. BioChaperone Combo is a formulation owner of Adocia combining the insulin analog basal glargine (Lantus®, Sanofi) and insulin analogue prandial lispro (Humalog®, Eli Lilly and Company). The technology BioChaperone® allows this combination of solubilizing the insulin glargine at neutral pH, pH of compatibility with insulin analogues prandial.
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The objective of this study is to document the exposure with the dose of BioChaperone Combo at three different doses in people with type 2 diabetes, with the aim of determining the relationship of proportionality to the dose.
“We are very pleased to initiate this study on BioChaperone Combo, designed to meet an important regulatory requirement.” commented Olivier Soula, deputy General Manager and R&D Director of Adocia. “With the positive results announced yesterday, this study should enable to strengthen all of the data that support a better performance of our combination compared to the premix in people with type 2 diabetes. ”
In this randomized, double-blind, cross-over in four periods, which will use a clamp euglycemic automated for 30 hours, 32 participants with type 2 diabetes will receive at random a sequence of four treatments, i.e. one of the three doses of BioChaperone Combo 75/25 (0,6 U/kg 0.8 U/kg or 1.0 U/kg) or a single dose of Humalog® Mix25TM to 0.8 U/kg, during four separate visits.
The main objective is the assessment of the proportionality to the dose of the total exposure to insulin, with three doses of BioChaperone Combo. The secondary objectives include the documentation of the dose response in relation to the metabolic effect total, the three doses of BioChaperone Combo, and the comparison of the pharmacodynamic and pharmacokinetic profiles of BioChaperone Combo (0.8 U/kg) with Humalog Mix25TM (0.8 U/kg). The objectives also include the evaluation of the safety and tolerance to the two treatments in these participants.
The results of this study are expected in the fourth quarter of 2017.
Adocia is the sponsor of this study, which will be conducted by Profile Neuss in Germany.
This trial is registered (NCT03180710) and will appear on clinicaltrials.gov.
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 five products in clinical phase and five 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 meet the specific needs of 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). In addition, an aqueous formulation of glucagon, human (BioChaperone Human Glucagon) has recently entered into clinical phase. Adocia is also developing 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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