Regulatory Filings • Jun 1, 2017
Regulatory Filings
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Lyon, France, June 1st, 2017 – 6 pm CET – Adocia (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 clinical study evaluating BioChaperone® Lispro, an "ultra-rapid" formulation of insulin lispro, compared to Fiasp® (faster-acting insulin aspart, Novo Nordisk), the only EMA-approved (Europe) and Health Canada-approved "ultra-rapid" acting insulin formulation, and Novolog® (insulin aspart, Novo Nordisk), a rapid-acting insulin analog, when administered using an insulin pump. BioChaperone Lispro incorporates Adocia's proprietary technology, BioChaperone®, which is designed to enable the acceleration of insulin absorption. BioChaperone Lispro has demonstrated an accelerated insulin action profile across multiple Phase 1/2 studies in people with type 1 and type 2 diabetes, when injected with insulin syringes and insulin pumps. BioChaperone Lispro is ready to enter phase 3 clinical studies. The present Phase 2 study will be the first to compare two "ultra-rapid" insulin formulations head-to-head.
"The advent of this new class of insulins is exciting, as there is an urgent need for fasteracting insulins to improve glycemic control in people with diabetes." said Dr. Bruce Bode, MD, FACE "These insulins may also play a critical role in advancing artificial pancreas efforts, improving the overall performance of these systems."
The study aims to compare the pharmacokinetic and pharmacodynamic profiles of BioChaperone Lispro U100 to those of Fiasp and Novolog in participants with type 1 diabetes under a euglycemic clamp procedure.
"This is the first independent study of BioChaperone Lispro conducted by Adocia since the termination of the Eli Lilly collaboration in January 2017. We are eager to evaluate BioChaperone Lispro's performance in pumps against that of FiAsp, which is the first approved insulin formulation in this new class." commented Olivier Soula, Adocia's Deputy General Manager and Director of R&D. "We expect to publish the topline clinical results before year end and we believe this clinical trial will further demonstrate the value of BioChaperone Lispro in the large and growing insulin pump segment."
In this double-blind, randomized, three-period crossover study, 42 participants with type 1 diabetes under a euglycemic clamp procedure will receive single doses (0.15 U/kg) of BioChaperone Lispro U100, Fiasp and Novolog, administered by an insulin pump (Medtronic MiniMed Paradigm® Veo) on three separate dosing visits.
Objectives of the study include the comparison of the glucose response obtained during the first hour after administration of BioChaperone Lispro U100 to those obtained after administration of Fiasp and Novolog and the evaluation of the pharmacokinetic profiles of BioChaperone Lispro U100, Fiasp and Novolog. Objectives also include the assessment of safety and tolerability of the three treatments in these participants.
This study will be sponsored by Adocia and performed by Profil Neuss in Germany.
The trial is registered 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 four clinicalstage products and six 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). Adocia is also developing an aqueous formulation of human glucagon (BioChaperone Human Glucagon), 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
| Adocia | Adocia Press Relations | Adocia Investor Relations |
|---|---|---|
| Gérard Soula | Europe | USA |
| Chairman and CEO | MC Services AG | The Ruth Group |
| [email protected] | Raimund Gabriel | Tram Bui |
| Ph. : +33 4 72 610 610 | [email protected] | [email protected] |
| Ph. : +49 89 210 228 0 | Ph.: +1 646 536 7035 | |
This press release contains certain forward-looking statements concerning Adocia and its business. Such forwardlooking 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. This press release and the information contained herein do not constitute an offer to sell or the solicitation of an offer to buy Adocia shares in any jurisdiction.
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