Adocia Initiates a Clinical Study on a High Concentration Formulation of the Ultra-Rapid Insulin BioChaperone Lispro

Regulatory News:

ADOCIA (Paris:ADOC) (Euronext Paris: FR0011184241 – ADOC) announced today the initiation of a Phase I clinical trial evaluating a new and more concentrated formulation of BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Eli Lilly and Company. This formulation uses Adocia’s proprietary BioChaperone technology, which enables the acceleration of insulin absorption.

There is a current trend towards insulin products with a higher concentration, primarily to meet the need for reduced injection volumes, but also to increase autonomy of patients using insulin pumps. Recently, the first concentrated rapid acting insulin has been approved in Europe and in the US. It is a new formulation of insulin lispro, Humalog U200 (Lilly), bioequivalent product to Humalog U100. While commercialized rapid insulin analogs, e.g. Humalog U200, are injected 5 to 15 minutes before or immediately after a meal, an ultra-rapid insulin may allow injection at the time of the meal, or even after the start of a meal, while improving post-prandial glycemic control.

"We are very excited to evaluate this more concentrated U200 formulation of BioChaperone Lispro, after the positive clinical results on the U100 formulation. Our goal is to test the potential bioequivalence of these two formulations” says Olivier Soula, Adocia’s R&D Director and Deputy General Manager. "This new formulation of BioChaperone Lispro could prove to be the first ultra-rapid insulin product at high concentration”.

The rationale for this study is to file for registration of BioChaperone Lispro U200 based on BioChaperone Lispro U100’s dossier. The study aims to compare pharmacokinetic and pharmacodynamic parameters of the two formulations of BioChaperone Lispro, U100 and U200, to determine the potential for bioequivalence. In this double-blinded, randomized, four-period cross-over study, 24 male and female healthy volunteers under euglycemic clamp will be treated with two single doses of BioChaperone Lispro U200 and two single doses of BioChaperone Lispro U100. The primary objective includes establishing the intra-subject variability of key bioequivalence parameters. This study is performed by Profil Neuss in Germany.

"There is a real need for reducing the volume of injected product for insulin pump and insulin pen users. Indeed, we observe a consistent increase in injected insulin doses, largely due to the rising number of overweight patients.” says Simon Bruce, MD, Adocia’s Chief Medical Officer.

About Adocia

To be a global leader in the innovative delivery of insulins and therapeutic proteins

Adocia is a clinical stage biotechnology company that specializes in the development of innovative formulations of already approved therapeutic proteins. It has a particularly strong expertise in the field of insulins. Adocia’s proprietary BioChaperone^® technological platform is designed to enhance the effectiveness and safety of therapeutic proteins and their ease of use for patients.

In December 2014, Adocia signed a partnership with Eli Lilly for the development and commercialization of its new formulation of insulin lispro, BioChaperone Lispro.

Adocia will continue to develop its fast-acting human insulin formulation internally. Two clinical studies are planned till year end, a post-meal glucose control study with HinsBet U100 and a PK/PD study with HinsBet U500. Adocia is also actively continuing the development of its BioChaperone Combo, a unique combination of insulin glargine, the gold-standard of basal insulin and insulin lispro, a reference in fast-acting insulin. Two phase Ib clinical studies have recently been initiated. A third clinical study, a dose-response in type 1 diabetic patients, is also scheduled for the fourth quarter of 2015.

In addition, Adocia launched a phase III clinical study in India on its product based on PDGF-BB, BioChaperone PDGF-BB, for treatment of the diabetic foot ulcer in August 2014.

Adocia has extended its activities to the formulation of monoclonal antibodies, which are gold-standard biologics for the treatment of various chronic pathologies (cancer, inflammation, etc.). Adocia is engaged in collaborative programs with two major pharmaceutical companies in this field.

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« Innovative medicine for everyone, everywhere »
Adocia’s therapeutic innovations aim to provide solutions in a profoundly changing global pharmaceutical and economic context, characterized by (i) an increased prevalence and impact of the targeted pathologies, (ii) a growing and ageing population, (iii) a need to control public health expenditures and (iv) an increasing demand from emerging countries.

Adocia is listed on the regulated market of Euronext in Paris (ISIN: FR0011184241; Reuters/Bloomberg ticker: ADOC, ADOC.PA, ADOC.FP) and is included in the Next Biotech, Tech 40 and SBF 120 indexes.

American Depositary Receipts representing Adocia common stock are traded on the US OTC market under the ticker symbol ADOCY.

For more information, visit: www.adocia.com

Disclaimer
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 Reference Document registered by the French Financial Markets Authority (Autorité des marchés financiers – AMF) on April 30, 2015 under number R.15-032 (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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