Adocia and Lilly Initiate a Phase 1b Study Evaluating Ultra-Rapid BioChaperone Lispro in Patients with Type 1 Diabetes Using Insulin Pump Therapy

Regulatory News:

ADOCIA (Paris:ADOC) (Euronext Paris: ADOC) and Eli Lilly and Company (NYSE: LLY) today announced 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, which is designed to accelerate insulin absorption.

This two-week study, under the Adocia-Lilly partnership, aims to compare the effects of BioChaperone Lispro and Humalog^® (insulin lispro rDNA origin) on post-meal glycemic control in type 1 diabetes patients using insulin pump therapy.

Insulin pump therapy, also known as continuous subcutaneous insulin therapy (CSII), is an alternative to multiple daily injections from insulin syringes or pens. The insulin pump provides a steady stream of rapid-acting insulin to the patient’s body, thus replacing basal insulin injections, and also provides bolus infusions in response to food intake. Using an ultra-rapid insulin in a pump could provide a significant impact around mealtimes, since the rapid onset would better match the quick rise in blood sugar that follows a meal.

"The number of diabetes patients using pumps is increasing for practical and medical reasons. Outpatient data using CSII are an important part of further documenting BioChaperone Lispro’s benefits for type 1 diabetes patients,” says Olivier Soula, Adocia’s R&D Director and Deputy General Manager.

In this crossover, randomized, double-blind study, 36 type 1 diabetes patients will receive continuous subcutaneous insulin injection of BioChaperone Lispro U100 and Humalog U100 in an outpatient setting over the course of two, 14-day periods. The main objective of this study is to compare post-meal glycemic control obtained after the bolus injection of either BioChaperone Lispro or Humalog relative to a solid meal stimulus. The pharmacokinetic profiles of both products will also be monitored. Continuous glucose monitoring will be performed throughout the period. This study will be sponsored by Adocia, and performed by Profil Neuss in Germany.

"Lilly’s foundation is built on innovation and discovery in the diabetes space,” says David Moller, Vice President, Lilly Research Laboratories. "The study of this new rapid insulin formulation in the context of an insulin pump is an important step in the ongoing BioChaperone Lispro development program.”

Additional clinical studies will be conducted this year in order to further document BioChaperone Lispro’s performance in other patient populations and prepare the product for Phase III testing.

This trial (EudraCT 2015-002808-81) is registered and appears on clinicaltrials.gov.

This press release contains forward-looking statements about the research collaboration between Adocia and Lilly related to BioChaperone Lispro and reflects Adocia’s and 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 risks and uncertainties and more generally of the risks related to the businesses of Lilly and Adocia, see Lilly's filings in the United States with the United States Securities and Exchange Commission (SEC) and Adocia’s filings in France with the French Financial Markets Authority (Autorité des marchés financiers – AMF). Neither Lilly nor Adocia undertake any duty to update such 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.

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