Adocia Initiates BC LisPram Phase 1 Clinical Trial in Pump for People with Type 1 Diabetes

• For the first time, a unique combination of two key hormones involved in glycemic control, a rapid acting insulin analog and an amylin analog, is tested in a single pump
  
• BioChaperone^® Lispro and Pramlintide coformulation’s safety, pharmacokinetic and glycemic control will be evaluated compared to insulin lispro

LYON, France, June 29, 2021 (GLOBE NEWSWIRE) -- Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical stage biopharmaceutical company focused on diabetes treatment and other metabolic diseases with innovative formulations of proteins and peptides, announced today the launch of a Phase 1 clinical study in collaboration with Dr. Ahmad Haidar, McGill University, Canada, to assess pharmacokinetic, glycemic control and safety of BioChaperone^® Lispro Pramlintide (BC LisPram) prandial formulation in 16 people with type 1 diabetes compared to rapid insulin lispro.

“We have demonstrated that lispro and pramlintide infused by two separate pumps improves glycemic control compared to lispro alone in an artificial pancreas¹ and most of my patients stated that they would prefer the coformulation if it were commercially available. So, we are very excited to study BC LisPram, which allows the use of only one pump to deliver both hormones,” declared Dr. Ahmad Haidar.

The medical benefits of pramlintide are scientifically demonstrated. Adding pramlintide to insulin improves glycemic control after a meal, induces weight loss, and induces a satiety effect. Pramlintide, despite being the only drug approved as an adjunct to insulin in type 1 diabetes, is underused as it requires three additional daily injections in addition to the multiple injections of insulin.

Adocia has developed two products, M1Pram in pen for Multiple Daily Injection, currently in Phase 2, and now BC LisPram for insulin pump delivery. Adocia has confirmed the attributes of pramlintide in previous clinical trials with M1Pram.

“We aim to offer the powerful combined effects of amylin and insulin to people with diabetes without increasing their burden. We are very glad to conduct this trial with Dr. Ahmad Haidar who has made a strong contribution by demonstrating the importance of pramlintide in pump as an adjunct to insulin in human,” declared Olivier Soula, Deputy CEO and R&D Director of Adocia.

About BioChaperone^® LisPram

BioChaperone^® Lispro Pramlintide (BC LisPram) is a fixed combination of two approved hormones analogs, the insulin analog lispro and the amylin analog pramlintide. The BioChaperone^® proprietary technology of Adocia stabilizes the coformulation of lispro and pramlintide, two peptides that are naturally not stable together in a liquid solution ready for injection.

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 several pre-clinical 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. The clinical pipeline also includes an aqueous formulation of human glucagon (BioChaperone^® Glucagon) for the treatment of hypoglycemia.

Adocia preclinical pipeline includes bi-hormonal combinations for diabetes treatment: two combinations of rapid acting insulin analogs and Pramlintide (BioChaperone^® Lispro Pram and BioChaperone^® Aspart Pram), a combination of insulin glargine with GLP-1 receptor agonists (BioChaperone^® Glargine Liraglutide). In addition, there are two bi-hormonal products for the treatment of obesity: a combination of glucagon and exenatide (BioChaperone^® GluExe) and a combination of pramlintide and exenatide (PramExe).

Adocia recently added a preclinical program to its pipeline with a cell therapy initiative focused on development of a hydrogel scaffold for use in people with type 1 diabetes. The first patent application supporting this program has been filed.

Contact Adocia

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 20, 2021 (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.

____________
¹ A. Haidar et al at McGill University Diabetes Care. 2020 Mar;43(3):597-606