Adocia and Lilly Initiate Phase 1b Study Evaluating Ultra-Rapid Insulin BioChaperone Lispro U100 in Healthy Japanese Subjects

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

Adocia (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®, which is designed to enable the acceleration of insulin absorption.

The study, under the Adocia-Lilly partnership, aims to compare the pharmacokinetic and pharmacodynamic profiles of BioChaperone Lispro to that of Humalog® (insulin lispro rDNA origin) in 15 healthy Japanese subjects placed under euglycemic clamp.

“Japan, like other Asian countries, is confronted with a rapidly growing diabetes epidemic, and patients are in need of new treatment options,” says Simon Bruce, Adocia’s Chief Medical Officer. “This study should serve to allow the inclusion of Japanese patients with diabetes in the phase 3 program, in line with our objective to prepare for a global registration plan for the product.”

In this double-blind, randomized, three-period crossover study, 15 healthy Japanese subjects placed under euglycemic clamp will receive three single dose administrations, separated by 1 to 14 days. Each subject will be randomly allocated to receive either three single doses of BioChaperone Lispro U100 (0.1, 0.2 and 0.4 U/kg) or one single dose of Humalog U100 (0.2 U/kg) and two single doses of BioChaperone Lispro U100 (0.1 and 0.2 or 0.2 and 0.4 U/kg) on three separate dosing visits.

Objectives also include the assessment of safety and tolerability of BioChaperone Lispro in these subjects.

This study will be sponsored by Adocia and performed by Profil Neuss in Germany.

This trial (EUDRACT 2015-004829-13) 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 and other risks and uncertainties and more generally of the risks related to the businesses of Lilly and Adocia, see Lilly's filings 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 undertakes 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/20160128006422/en/

Lilly
Candace Johnson
Communications Manager, Lilly Diabetes
[email protected]
www.lilly.com
or
Adocia
Gérard Soula - [email protected]
Président Directeur Général d’Adocia
Tél. : +33 4 72 610 610
or
Relations média
ALIZE RP
Caroline Carmagnol et Florence Portejoie
[email protected]
[email protected]
Tel.: + 33 1 44 54 36 61

Source: Adocia

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