Lyon, France – (BUSINESS WIRE) – Regulatory news:
Adocia (Euronext Paris: FR0011184241 – ADOC) (Paris: ADOC), a clinical-stage biopharmaceutical company focused on the treatment of diabetes and other metabolic disorders with innovative formulations of proteins and peptides, today announced the start of a Phase 1 clinical trial – Study in collaboration with Dr Ahmad Haidar, McGill University, Canada, to evaluate the pharmacokinetics, glycemic control and safety of the prandial formulation of BioChaperone® Lispro Pramlintide (BC LisPram) in 16 patients with type 1 diabetes compared to rapid Insulin lispro.
“We have shown that Lispro and Pramlintide, infused through two separate pumps, improve glycemic control compared to Lispro alone in an artificial pancreas1 and most of my patients said they would prefer the coformulation if it was commercially available would. We are therefore very excited to investigate BC LisPram, which allows the use of just one pump to deliver both hormones, ”said Dr. Ahmad Haidar.
The medical benefits of pramlintide have been scientifically proven. The addition of pramlintide to insulin improves glycemic control after a meal, leads to weight loss and leads to a satiety effect. Pramlintide, while the only drug approved as an additive to insulin in type 1 diabetes, is under-used because it requires three additional injections per day in addition to multiple insulin injections.
Adocia has developed two products, M1Pram in pen for multiple daily injections, currently in phase 2, and now BC LisPram for insulin pump administration. Adocia has confirmed the properties of Pramlintide in previous clinical studies with M1Pram.
“Our goal is to offer people with diabetes the powerful combined effects of amylin and insulin without increasing their exposure. We are very pleased to conduct this study with Dr. Ahmad Haidar, who made a strong contribution by showing the importance of pramlintide in the pump as an additive to insulin in humans, ”said 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 hormone analogues, the insulin analogue Lispro and the amylin analogue Pramlintide. Adocia’s proprietary BioChaperone® technology stabilizes the co-formulation of Lispro and Pramlintide, two peptides that are naturally not stable together in a liquid, ready-to-inject solution.
Adocia is a clinical-stage biotechnology company specializing in developing innovative formulations of therapeutic proteins and peptides for the treatment of diabetes and metabolic diseases. In diabetes, Adocia’s injectable treatments portfolio is one of the largest and most diverse in the industry, with five clinical-stage products and several pre-clinical products. The proprietary BioChaperone® technology platform is designed to improve the efficacy and / or safety of therapeutic proteins while making them easier to use for patients. Adocia adapts BioChaperone® to each protein for a specific application.
Adocia’s clinical pipeline includes four novel insulin formulations for the prandial treatment of diabetes: two ultra-fast formulations of the insulin analogue Lispro (BioChaperone® Lispro U100 and U200), a combination of basal insulin glargine and fast-acting insulin Lispro (BioChaperone® Combo), and a combination of one prandial insulin with the amylin analogue pramlintide M1Pram. The clinical pipeline also includes an aqueous formulation of human glucagon (BioChaperone® Glucagon) for the treatment of hypoglycemia.
Adocia’s preclinical pipeline includes bihormonal combinations for the treatment of diabetes: two combinations of fast-acting insulin analogues and pramlintide (BioChaperone® Lispro Pram and BioChaperone® Aspart Pram), a combination of insulin glargine with GLP-1 receptor agonists (BioChaperone® Glargine Liraglutide). There are also two bihormonal 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 with a cell therapy initiative focused on developing a hydrogel scaffold for people with type 1 diabetes. The first patent application in support of this program has been filed.
This press release contains certain forward-looking statements about Adocia and its business. Such forward-looking statements are based on assumptions that Adocia believes to be appropriate. However, there can be no assurance that the estimates made in any such forward-looking statement will be verified as such estimates are subject to numerous risks, including those set out in the “Risk Factors” section of the universal registration document filed with the French Authorité des marchés financiers on March 20 April 2021 (a copy of which is available at www.adocia.com) and on developments in the economic conditions of the financial markets and the markets in which Adocia operates. The forward-looking statements contained in this press release are also subject to risks that Adocia is not yet aware of or that Adocia does not currently consider to be material. The occurrence of all or some of these risks could cause the actual results, financial conditions, performance or achievements of Adocia to differ materially from such forward-looking statements. This press release and the information contained herein constitute neither an offer to sell nor a solicitation of an offer to buy Adocia shares in any jurisdiction.
1 A. Haidar et al. from McGill University Diabetes Care. March 2020; 43 (3): 597-606