Adocia Announces M1Pram Clinical Data Presentation at the American Diabetes Association® 80th Scientific Sessions – Virtua...

Regulatory News:

Adocia (Paris:ADOC) (Euronext Paris: FR0011184241 – ADOC), a clinical stage biopharmaceutical company focused on the treatment of diabetes and other metabolic diseases with innovative formulations of approved proteins, announced today that an abstract relative to bi-hormonal treatment ADO09 (M1Pram) has been accepted for a poster presentation at the upcoming 80th Scientific Sessions of the American Diabetes Association® (ADA). The ADA annual meeting will take place from June 12th until 16th, 2020 as the inaugural virtual event.

The poster presented by Adocia will describe the results of M1Pram combination in phase 1 on type 1 diabetic patients. The objective of this study was to compare M1Pram formulation with Novolog®, the widely used fast acting insulin Aspart. In this study, M1Pram offered better glycemic control with less insulin consumption and also significant weight loss.

“We are proud to present at ADA our promising results of M1 Pram combination. We believe that adding Pram to prandial insulin should be the next generation of mealtime treatment”, commented Dr Olivier Soula. “We now intend to pursue the development of M1Pram in a three-month Phase 2 clinical trial”.

Details of the accepted abstract presented below:

Poster # 2020-LB-7039-Diabetes, ADO09, a Coformulation of Pramlintide (PRAM) and Insulin A21G, Improves Postprandial Glucose vs. Novolog in Type 1 Diabetes (T1D)

Presenting Author: Dr. Grégory Meiffren

Session: 112-LB in category 12-E Clinical Therapeutics/New Technology—Insulins.

About the ADA Scientific Sessions – Virtual Experience

The American Diabetes Association’s Scientific Sessions offer researchers and health care professionals from around the globe an exclusive opportunity to share ideas and gain knowledge about the recent advances in diabetes research, treatment, and care. Attendees will have access to more than 3,000 original research presentations, take part in thought-provoking speaking engagements with leading diabetes experts, and expand their professional networks. ADA Website: https://professional.diabetes.org/scientific-sessions

About Insulin Pramlintide Combinations

Adocia has the ambition to make the insulin treatment more physiologic by combining a well-known synergetic hormone namely amylin analog, pramlintide. In healthy people, amylin is co-secreted with insulin by β-islet of the pancreas to delay the gastric emptying, to inhibit the glucagon secretion and to trigger a satiety effect. This combination has been a challenge for a long time as insulin and pramlintide are not compatible in water.

Adocia has made two inventions to propose a stable liquid combination: one using BioChaperone and one using an insulin analog stable at pH4 namely M1 (main metabolite of glargine), deamidated A21 human insulin. The technology BioChaperone permits to combine at pH7 either human insulin BC InsPram, or insulin analog BC LisPram for Lispro (Humalog) and BC AsPram for Aspart (Novolog).

Finally, Adocia has chosen to develop two pramlintide combinations with two different insulin PK: one normal with human insulin analog (M1Pram) and one rapid with insulin analog lispro (BC LisPram). This 2 different insulin kinetics may be more adapted either for the bolus injections using a pen or for the continuous injection controlled by an insulin pump with a closed-loop algorithm. M1Pram and BC InsPram have been both tested in type 1 diabetes patients. Adocia intends to develop the best combination for pen and for pump to treat first type 1 diabetes and later to treat insulin-dependent type 2 diabetes.

Last M1Pram results published last April 2020.

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. Adocia aims to expand its portfolio towards the treatment of other metabolic diseases and their comorbidities.

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 the 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 2 combinations of a prandial insulin with amylin analog pramlintide M1Pram (ADO09) and BC LisPram. It also includes an aqueous formulation of human glucagon (BioChaperone® Glucagon) for the treatment of hypoglycemia. Adocia preclinical pipeline includes 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. Adocia is also exploring in preclinic the potential of its M1Pram combination to treat people with type 2 diabetes suffering from neurological comorbidities, including Alzheimer’s disease.

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 Reference 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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Adocia Gérard Soula Chairman and CEO [e-mail] Ph.: [phone]

Adocia Press Relations Europe MC Services AG Raimund Gabriel [e-mail] Ph.: [phone]

Adocia Investor Relations USA The Ruth Group Tram Bui [e-mail] Ph.: [phone]