French biopharmaceutical company ADOCIA, focused on the treatment of diabetes and other metabolic diseases with innovative formulations of approved proteins, announced the initiation of a Phase 1 study of BioChaperone® Pramlintide Insulin (BC Pram Ins), its ready-to-use co-formulation of pramlintide and human insulin.
The BioChaperone proprietary technology enables the solubilization and stabilization, in aqueous solution at neutral pH, of pramlintide, the only FDA-approved amylin analog for the treatment of diabetes, hence allowing its combination with insulin. Adocia customizes BioChaperone to each protein for a given application to address specific patient needs.
This study aims to investigate the pharmacokinetics, pharmacodynamics, and the safety and tolerability of BC Pram Ins in people with type 1 diabetes compared to separate injections of human insulin (Humulin, Eli Lilly) and pramlintide (Symlin, AstraZeneca), and also to an injection of insulin lispro (Humalog, Eli Lilly).
Pramlintide (Symlin, AstraZeneca), a short-acting amylin analog, is the only molecule in this class approved by FDA for the treatment of diabetes. Pramlintide is approved in the USA for both type 1 and type 2 diabetes as an adjunct therapy to insulin treatment.
Adocia, based in Lyon, France, has clinical pipeline that 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), a rapid-acting formulation of human insulin (HinsBet U100), and a prandial combination of human insulin with amylin analog pramlintide (BioChaperone Pramlintide Insulin).