LYON, France--(BUSINESS WIRE)--Regulatory News:
Adocia (Paris:ADOC) (Euronext Paris: FR0011184241- ADOC), the clinical biopharmaceutical company focused on developing innovative formulations of approved proteins for the treatment of diabetes, announced today the initiation of a Phase 1b clinical trial evaluating the dose-linearity of BioChaperone® Combo 75/25 at three different doses in people with type 2 diabetes. BioChaperone Combo is a proprietary formulation combining the long-acting insulin analog glargine (Lantus®, Sanofi) and the fast-acting insulin analog lispro (Humalog®, Eli Lilly and Company). BioChaperone® technology enables this combination by solubilizing insulin glargine at neutral pH, at which it is compatible with fast-acting insulin analogs.
This study aims to document the dose exposure of BioChaperone Combo across three different doses in people with type 2 diabetes in order to assess dose-proportionality.
“We are very pleased to initiate this new study on BioChaperone Combo which is designed to answer an important regulatory requirement.” commented Olivier Soula, Deputy General Manager and R&D Director of Adocia. “Together with the positive topline results announced yesterday, this study should serve to strengthen the body of evidence supporting the improved performance of our combination vs. premix in people with type 2 diabetes.”
In this double-blinded, randomized, four-period crossover trial, using automated 30-hour euglycemic clamp, 32 participants with type 2 diabetes mellitus will be randomly allocated to a sequence of four treatments, i.e. one of three single doses of BioChaperone Combo 75/25 (0.6 U/kg, 0.8 U/kg or 1.0 U/kg) or one single dose of Humalog® Mix25TM at 0.8 U/kg, on four separate dosing visits.
The primary endpoint is assessment of dose-proportionality for the total insulin exposure across the three doses of BioChaperone Combo. Secondary endpoints include documentation of the dose-response relationship for the total metabolic effect of the three doses of BioChaperone Combo and the comparison of the pharmacodynamic and pharmacokinetic profiles of BioChaperone Combo (0.8 U/kg) with those of Humalog Mix25TM (0.8 U/kg). Objectives also include the assessment of safety and tolerability of both treatments in these participants.
Study results are expected in Q4 2017.
This study will be sponsored by Adocia and performed by Profil Neuss in Germany.
The trial is registered (NCT03180710) and will appear on clinicaltrials.gov.
Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins. Adocia’s portfolio of injectable treatments for diabetes, featuring five clinical-stage products and five preclinical products, is among the largest and most differentiated of the industry.
The proprietary BioChaperone® technological platform is designed to enhance the effectiveness and/or safety of therapeutic proteins while making them easier for patients to use. Adocia customizes BioChaperone to each protein for a given application in order to address specific patient needs.
Adocia’s clinical pipeline includes four novel insulin formulations for the treatment of diabetes: two ultra-rapid formulations of insulin analogs (BioChaperone Lispro U100 and U200), a rapid-acting formulation of human insulin (HinsBet U100) and a combination of basal insulin glargine and rapid-acting insulin lispro (BioChaperone Combo). Additionally, an aqueous formulation of human glucagon (BioChaperone Human Glucagon) has recently entered clinical testing. Adocia is also developing two combinations of insulin glargine with GLP-1s (BioChaperone Glargine Dulaglutide and BioChaperone Glargine Liraglutide), two combinations of insulin lispro with synergistic prandial hormones (BioChaperone Lispro Pramlintide and BioChaperone Lispro Exenatide), and a concentrated, rapid-acting formulation of human insulin (HinsBet U500), all of which are in preclinical development.
Adocia aims to deliver “Innovative medicine for everyone, everywhere.”
To learn more about Adocia, please visit us at www.adocia.com
This press release contains certain forward-looking statements concerning Adocia and its business. Such forward-looking statements are based on assumptions that Adocia considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the “Risk Factors” section of the Reference Document filed with the French Autorité des marchés financiers on April 11, 2017 (a copy of which is available on www.adocia.com) and to the development of economic conditions, financial markets and the markets in which Adocia operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Adocia or not currently considered material by Adocia. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Adocia to be materially different from such forward-looking statements.
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