Adocia and Lilly Announce Successful Completion of an Insulin Pump Study with BioChaperone Lispro in People with Type 1 Diabetes

• BioChaperone Lispro U100 demonstrated a statistically significant increase in insulin exposure over the first 30 minutes after a mealtime bolus compared to Humalog
• An accelerated absorption profile of BioChaperone Lispro U100 was observed across the three insulin delivery devices tested
• BioChaperone Lispro U100 and Humalog showed similar safety results and were well tolerated

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

Adocia (Paris: ADOC) and Eli Lilly and Company (NYSE: LLY) announced today successful completion of an insulin pump study under the Adocia-Lilly partnership evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This formulation uses Adocia’s proprietary technology BioChaperone®, designed to accelerate insulin absorption.

This study was the first to compare, in people with type 1 diabetes, the post-prandial glycaemia and pharmacokinetic response to an individualized mixed meal after a bolus of BioChaperone Lispro and Humalog® (insulin lispro rDNA origin), administered with two different Continuous Subcutaneous Insulin Infusion (CSII) systems (Roche Accu-Chek® Spirit and Medtronic Paradigm® Veo™) immediately before a meal. The study also investigated the effects of both agents administered subcutaneously with a syringe.

“We are pleased to confirm that BioChaperone Lispro consistently delivered ultra-rapid insulin absorption compared to Humalog in the two insulin pumps tested. This increased early insulin exposure translated into improved post-prandial glucose control.” said Simon Bruce, MD, Adocia’s Chief Medical Officer. “Thus, BioChaperone Lispro has demonstrated a consistent absorption profile across multiple studies, different populations, and, now, different delivery modes.”

This was a two-part study. The first part comparing the products in the Roche Accu-Chek® Spirit pump did not clearly demonstrate an advantage for BioChaperone Lispro. The second part involved more subjects and included three devices: Roche Accu-Chek® Spirit pump, Medtronic Paradigm® Veo™ pump and insulin syringe. In this latter part 44 subjects were enrolled in a randomized, double-blind, 2-treatment, 4-period cross-over, active controlled clinical trial to investigate BioChaperone Lispro compared to Humalog in CSII. During the treatment period, patients made four, 2-day visits to the clinic interspersed with wash-out periods. On the day of each visit, patients were subjected to a meal-tolerance test (MTT) after receiving one of the two treatments immediately prior to the meal using one of the two pumps (Day 1), or the same treatment using a syringe (Day 2) on top of basal delivery.

One primary objective of the second part of the study was to compare the absorption profile of BioChaperone Lispro vs. Humalog, when administered immediately before an individualized mixed meal, with the selected pump models and syringes. BioChaperone Lispro U100 demonstrated a statistically significant increase in insulin exposure over the first 30 minutes compared to Humalog in the two pumps tested: early exposure was increased by 33% in the Roche pump (primary endpoint, p=0.0007) and by 54% in the Medtronic pump (p

BioChaperone Lispro was associated with a consistent pattern of improved response to mixed meal testing compared to Humalog. In the Roche pump a statistically significant 83% reduction (p=0.0018) in the 2hr blood glucose excursion has been shown while a non-significant 12% reduction in the 2hr blood glucose excursion has been observed with the Medtronic pump. When delivered as a bolus from syringes, on top of basal delivery with an insulin pump, BioChaperone Lispro was also associated with significant reductions in the 2hr blood glucose excursion vs. Humalog (-56% with the Roche pump (p=0.0008) and -61% with the Medtronic pump (p

Both BioChaperone Lispro and Humalog were similarly well tolerated. No new or unexpected safety findings were observed and no local reactions were seen on the site of administration for either treatment.

The registry on clinicaltrials.gov for this trial (NCT02562313) has been updated.

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 http://www.lilly.com and www.lilly.com/newsroom/social-channels

About ADOCIA

Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of already-approved therapeutic proteins for the treatment of diabetes. 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/20161216005532/en/

Contact Lilly
Julie Williams
Communications Manager, Lilly Diabetes
Mobile: +1.317.627.4056
[email protected]
www.lilly.com
or
Contact Adocia
Gérard Soula
President & CEO
Ph.: +33 4 72 610 610
[email protected]
or
Adocia Media Relations Europe
MC Services AG
Raimund Gabriel
Ph.: +49 89 210 228 0
[email protected]
[email protected]
or
Adocia Investor relations USA
The Ruth Group - Tram Bui
Ph.: +646.536.7035
[email protected]

Source: Adocia

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