Adocia Launches Phase IIa Clinical Trial for Its Ultra-Fast Acting Formulation of Analog Insulin

The aim is to confirm on type I diabetic patients the positive results obtained during phase I

Regulatory News :

Adocia (Paris:ADOC) (Euronext Paris: FR0011184241 - ADOC), a biotechnology company specialized in the development of 'best-in-class' medicines from already approved therapeutic proteins, in particular proteins and oncologic treatments, launches today a phase IIa clinical trial on its ultra-fast acting formulation of insulin Lispro (Humalog®, Eli Lilly) using its proprietary technology BioChaperone®).

This clinical trial aims to demonstrate that the BioChaperone Lispro formulation acts faster than Humalog, which would allow patients to achieve a better glycemic control after a meal. During this study, pharmacodynamic and pharmacokinetic profiles of the BioChaperone Lispro formulation will be compared to those of Humalog in a cross-over design on 36 type I diabetic patients under euglycemic clamp. The first patients of this double-blind study conducted by Profil, a German CRO specialized in diabetes, have already been treated. Results from this study are expected during the second quarter of 2014.

Adocia is therefore entering the second stage of the clinical development plan of its ultra-fast acting analog insulin. During the first phase I clinical study, performed by Eli Lilly on healthy volunteers, the BioChaperone Lispro formulation reached all its predefined clinical endpoints.

"The objective of our ultra-fast analog insulin is to enhance post-prandial glycemic control in order to avoid hyperglycemia, which is responsible for long term side-effects of diabetes like retinopathy or cardiovascular issues", said Olivier Soula, VP R&D director at Adocia. "After this second stage, we intend to follow an accelerated clinical development pathway comparable to the one taken by Novo Nordisk with its reformulation of insulin Aspart."

"During preclinical studies, we demonstrated that BioChaperone has the same accelerating effect on all three fast-acting analog insulins on the market, namely Humalog, NovoLog® (Novo Nordisk) and Apidra® (Sanofi). This clinical trial on Humalog should establish the human proof of concept for all these insulins, which represent a USD 5 billion market," said Gerard Soula, CEO of Adocia.

About diabetes:

Worldwide, more than 382 million individuals are currently suffering from diabetes (with a forecast of 592 million individuals by 2030, i.e. a 51% increase, reaching 70% in emerging countries).(International Diabetes Federation).

The markets targeted by Adocia represent more than USD20 billion (USD17 billion for insulin therapy and USD3 billion for diabetic foot ulcer healing) (IMS Health).

About Adocia:

To be a global leader for the formulation of therapeutic proteins
Adocia is a biotech company specialized in the development of best-in-class drugs from the innovative formulation of certain already-approved therapeutic proteins.
Adocia is specialized in insulin therapy and the treatment of the diabetic foot, one of the main complications of diabetes.
Adocia successfully completed two phases I and II studies on the formulation of a fast-acting human insulin and obtained promising phase I/II results on a diabetic foot ulcer-healing product. Furthermore, Adocia has launched mid-November a Phase I clinical trial on a unique combination of fast-acting insulin and slow-acting insulin, for an optimal insulin therapy with one single product.

Fight cancer by enhancing oncology treatments targeting
Late in 2013, Adocia acquired an exclusive license on a nanotechnology which improves oncology treatments efficacy by targeting their action to solid tumors. This nanotechnology, called DriveIn®, is remarkably efficient in carrying active molecules and delivering them within solid tumors. This new platform in nanotechnology is an exceptional opportunity to enter the oncology market by improving the efficacy of already approved treatments.
Adocia develops proprietary products based on doxorubicin and docetaxel, two of the most used anti-tumoral treatments, which could greatly benefit from an enhanced intra-cellular delivery. Adocia will also propose the DriveIn technology to pharmaceutical companies to optimize the efficacy of their own proprietary molecules.

"Innovative medicine for everyone, everywhere"
Through its BioChaperone® state-of-the-art technological platform, Adocia intends to enhance the effectiveness and safety of therapeutic proteins and their ease of use for patients, with the aim of making these medicines accessible to the broadest public.
Based on its experience and recognized know-how, Adocia has extended its activities to the formulation of monoclonal antibodies, which are gold standard molecules for the treatment of numerous chronic pathologies (oncology, inflammation, etc.). In this field, Adocia is engaged in collaborative programs with two major pharmaceutical companies.
Adocia's therapeutic innovations aim at bringing solutions to a profoundly changing global pharmaceutical and economic context, characterized in particular by the increased prevalence and impact of the targeted pathologies, population growth and ageing, the need to control public health expenditures and increasing demand from emerging countries.

Adocia is listed on the regulated market of Euronext in Paris (ISIN: FR0011184241, mnemo / Reuters / Bloomberg: ADOC, ADOC.PA, ADOC.FP) and its share included in the Next Biotech index.
For more information: 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 "Risk Factors" section of the Reference Document registered by the Autorité des marchés financiers on April 25, 2013 under number R13-017 (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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