Adocia and Lilly initiate a new Phase 1b study of repeat administration of ultra-rapid BioChaperone Lispro in patients with type 2 diabetes

LYON, France & INDIANAPOLIS--(BUSINESS WIRE)-- Regulatory News:

Adocia (Paris: ADOC) (Euronext Paris: ADOC) and Eli Lilly and Company (NYSE: LLY) announced today the initiation of a Phase 1b clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This formulation uses Adocia’s proprietary technology, BioChaperone, to accelerate insulin absorption.

This study, under the Adocia-Lilly partnership, aims to measure the effect of BioChaperone Lispro injected at mealtime on post-meal glycemic control in type 2 diabetes patients compared to that of Humalog® (insulin lispro rDNA origin) over the same two-week period. Commercialized fast-acting insulin analogs are usually injected before the meal. An ultra-rapid insulin aims to allow injection at the time of the meal, or even after the start of a meal, with the goal of reducing the magnitude of glycemic excursions. The first clinical study conducted by the two companies demonstrated that BioChaperone Lispro was associated with a 61 percent reduction in post-prandial glucose excursions over the first two hours post-meal compared to Humalog.

“This new clinical study is designed to document the potential benefit of BioChaperone Lispro in patients with type 2 diabetes, a population representing about 90 percent of people living with diabetes,” said Olivier Soula, Adocia’s R&D Director and Deputy General Manager. “This study is similar in design to one we recently launched in people with type 1 diabetes.”

In this crossover, randomized, double-blind study, 50 subjects with type 2 diabetes will receive multiple daily doses of BioChaperone Lispro and multiple daily doses of Humalog over two periods of 14 days each. The main objective of this study is to compare the post-meal glycemic control obtained after the injection of either BioChaperone Lispro or Humalog immediately before the meal. The pharmacokinetic profiles of both products will also be monitored. This study will be sponsored by Adocia, and performed by Profil Neuss in Germany.

“Many patients with type 2 diabetes require mealtime insulin in order to adequately control their disease,” said David E. Moller, Vice President, Lilly Research Laboratories. “It’s important that we continue to investigate new treatment options that could potentially help people better manage their diabetes.”

Additional clinical studies are being planned.

This trial (EudraCT 2015-00-1865-17) is registered and will appear on clinicaltrials.gov.

This press release contains forward-looking statements about the research collaboration between Adocia and Lilly related to BioChaperone Lispro and reflects Lilly's current beliefs. However, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. There is no guarantee that the research collaboration will yield successful results or that either company will achieve the anticipated benefits, or that BioChaperone Lispro will achieve additional positive study results, or will achieve regulatory approval. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission (SEC) and Adocia’s filings with Autorité des Marchés Financiers (AMF). Lilly and Adocia undertake no duty to update forward-looking statements.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

About Adocia

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. To learn more about Adocia, please visit us at www.adocia.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20150929006646/en/

Contact Lilly
Candace Johnson, Mobile: +1-317-755-9143
Communications Manager, Lilly Diabetes
[email protected]
www.lilly.com
or
Contact Adocia
Gérard Soula, +33 4 72 610 610
President & CEO
[email protected]
or
Relations média
ALIZE RP
Caroline Carmagnol and Florence Portejoie, + 33 1 44 54 36 61
[email protected]
[email protected]

Source: Adocia

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