- The purpose of the comparative study is to demonstrate safety and efficacy of BioChaperone Lispro (BC Lispro) using Tonghua Dongbao (THDB) lispro as the drug substance.
- In nine previous studies, BC Lispro demonstrated significant improvement compared to Humalog, Aspart and Fiasp, while also proving to be safe and well tolerated.
- Trial design approved by BfArM and FDA to enable pivotal Phase 3 trials in Europe and U.S.
Regulatory News:
Adocia (Euronext Paris: FR0011184241 ADOC- the "Company") (Paris:ADOC), a clinical stage biopharmaceutical company focused on the treatment of diabetes and other metabolic diseases with innovative formulations of approved proteins, announced today the initiation of a comparative study to demonstrate safety and efficacy of BC Lispro using with insulin lispro manufactured by Tonghua Dongbao in patients with type 1 diabetes. The authorization from the German Federal Institute for Drugs and Medical Devices Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) was granted on July 21st, 2020. In addition, the U.S. Food and Drug Administration (FDA) granted approval for the Investigational New Drug (IND) application on July 29th, 2020. The approvals by BfArM and the FDA ensure a clear path to initiate pivotal Phase 3 trials for BC Lispro in Europe and the U.S. following a successful comparative study.
"We are pleased to obtain the approval from the German BfArM and the U.S. FDA to initiate this comparative study required before Phase 3," commented Olivier Soula, Deputy CEO of Adocia. "We thank Tonghua Dongbao team for this impressive work which is an important step to deliver this product to patients worldwide."
The CT037 study compares BC Lispro manufactured with insulin lispro from Tonghua Dongbao to US-approved Humalog and EU-approved Humalog reference products so the results allow to address US and EU markets. Additionally, the study also includes the comparison with BioChaperone reconstituted with Humalog (Eli Lilly), as used by Adocia in previous Type 1 diabetes trials.
The four arms of the CT037 trial:
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The randomized, double-blind, crossover trial will be performed in Germany with 28 type 1 diabetes patients, coordinated by Profil, a German full-service CRO specialized in diabetes and obesity.
About BioChaperone Lispro
BioChaperone Lispro (BC Lispro) is an ultra-rapid formulation of prandial insulin lispro that incorporates Adocia's BioChaperone proprietary technology. BioChaperone is designed to enable the acceleration of insulin absorption. BC Lispro has previously demonstrated an accelerated insulin action profile across nine Phase 1/2 studies in people with type 1 and type 2 diabetes compared to insulin analog lispro (Humalog, Eli Lilly) and insulin aspart (Novolog, Novo Nordisk), administered either with insulin syringes or by insulin pumps. Moreover, BC Lispro U100 has demonstrated significant improvement in terms of performance compared to Humalog across six clinical studies.
Since 2018, Adocia and Chinese company Tonghua Dongbao have a strategic alliance to develop and commercialize BC Lispro in China and other Asian and Middle East territories. In addition, Tonghua Dongbao supplies Adocia with insulin lispro and insulin glargine globally (with the exception of China), enabling Adocia to advance its key programs BioChaperone Lispro and BioChaperone Combo and to diversify partnership opportunities. Adocia retains the rights to develop BC Lispro in the US, Europe, Japan and Latin America and the formulation is already set for licensing in these regions.
For more information on BC Lispro, please visit our website: www.adocia.com/products/biochaperone-ultra-fast-analog-insulin
About Adocia
Adocia is a clinical-stage biotechnology company that specializes in the development of innovative formulations of therapeutic proteins and peptides for the treatment of diabetes and metabolic diseases. In the diabetes field, Adocia's portfolio of injectable treatments is among the largest and most differentiated of the industry, featuring five clinical-stage products and three preclinical-stage products. The proprietary BioChaperone technological platform is designed to enhance the effectiveness and/or safety of therapeutic proteins while making them easier for patients to use. Adocia customizes BioChaperone to each protein for a given application.
Adocia's clinical pipeline includes four novel insulin formulations for prandial treatment of diabetes: two ultra-rapid formulations of insulin analog lispro (BioChaperone Lispro U100 and U200), a combination of basal insulin glargine and rapid-acting insulin lispro (BioChaperone Combo) and one combination of a prandial insulin with amylin analog pramlintide M1Pram (ADO09). The clinical pipeline also includes an aqueous formulation of human glucagon (BioChaperone Glucagon) for the treatment of hypoglycemia.
Adocia preclinical pipeline includes three products: a combination of rapid human insulin analogues and Pramlintide (BioChaperone LisPram), a combination of insulin glargine with GLP-1 receptor agonists (BioChaperone Glargine GLP-1) for the treatment of diabetes and a ready-to-use combination of glucagon and a GLP-1 receptor agonist (BioChaperone Glucagon GLP1) for the treatment of obesity.
In 2018, Adocia and Chinese insulin leader Tonghua Dongbao entered a strategic alliance. In April 2018, Adocia granted Tonghua Dongbao licenses to develop and commercialize BioChaperone Lispro and BioChaperone Combo in China and other Asian and Middle Eastern territories. The licensing agreements included USD 50 million upfront and up to USD 85 million development milestones, plus double-digit royalties on sales. In June 2018, Tonghua Dongbao agreed to manufacture and supply active pharmaceutical ingredients insulin lispro and insulin glargine to Adocia globally, excluding China, to support Adocia's portfolio development and commercialization.
Adocia aims to deliver "Innovative medicine for everyone, everywhere."
To learn more about Adocia, please visit us at www.adocia.com
Disclaimer
This press release contains certain forward-looking statements concerning Adocia and its business. Such forward-looking statements are based on assumptions that Adocia considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the "Risk Factors" section of the Universal Registration Document filed with the French Autorité des marchés financiers on April 22, 2020 (a copy of which is available at www.adocia.com) and to the development of economic conditions, financial markets and the markets in which Adocia operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Adocia or not currently considered material by Adocia. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Adocia to be materially different from such forward-looking statements.
This press release and the information contained herein do not constitute an offer to sell or the solicitation of an offer to buy Adocia shares in any jurisdiction.
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Contacts:
Adocia
Gérard Soula
Chairman and CEO
contactinvestisseurs@adocia.com
Ph.: +33 4 72 610 610
Adocia Press Relations Europe
MC Services AG
Raimund Gabriel
adocia@mc-services.eu
Ph.: +49 89 210 2280
Adocia Investor Relations USA
The Ruth Group
Tram Bui
tbui@theruthgroup.com
Ph.: +1 646 536 7035
