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, which is designed to accelerate insulin absorption.
This new study under the Adocia-Lilly partnership aims to compare the effect of BioChaperone Lispro, injected either at mealtime or 15 minutes after the meal, on post-meal glycemic control in type 1 diabetes patients 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.
“This new clinical study aims to further document the potential benefit of BioChaperone Lispro,” says Olivier Soula, Adocia’s R&D Director and Deputy General Manager. “We continue to move rapidly to characterize the clinical effects of the ultra-rapid insulin lispro profile and prepare the product for Phase 3 clinical testing.”
In this crossover, randomized, double-blind study, 36 type 1 diabetes patients will receive multiple daily doses of BioChaperone Lispro and Humalog over two periods of 14 days each. The main objective is to compare post-meal glucose profiles after identical bolus injections of either BioChaperone Lispro or Humalog relative to a solid meal stimulus. Additionally the study will document the safety and efficacy of an ultra-rapid insulin absorption profile in an outpatient setting. This study will be sponsored by Adocia, and performed by Profil Neuss in Germany.
“Based on the success of the initial single-dose study, we are moving the investigational program forward to multiple daily dosing -- including evaluating effects on mixed meal testing, and safety and ease of use in the outpatient setting,” said Simon Bruce, Adocia’s Chief Medical Officer.
Additional Phase 1b clinical studies will be conducted this year in order to understand performance for additional diabetic patient needs.
This trial (NCT02528396) 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 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. Lilly 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.
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.