Nanexa AB announced that the European Medicines Agency has approved the company's clinical trial application for the Phase I study with NEX-22. NEX-22 is a long-acting depot formulation of the GLP-1 analogue liraglutide with Nanexa's patented PharmaShell® system. The goal is to create a GLP-1 product that can be administered once a month in the treatment of Type 2 diabetes.

The study will be performed in collaboration with the contract research organisation Profil in Germany, which is highly specialized in early clinical studies in diabetes and obesity. The study is divided into several consecutive dose groups where single doses of NEX-22 will be administered to patients with Type 2 diabetes to study pharmacokinetics, safety and tolerability. Liraglutide and other GLP-1 analogues have rapidly become important in the treatment of Type 2 diabetes and obesity.

The global market for this type of products is very large and is growing with increasing prevalence of both Type 2 diabetes and obesity. Sales of GLP-1 compounds show strong growth and GLP-1 and GLP-1/GIP drugs are expected to reach sales of over USD 70 billion by 2029 for Type 2 diabetes.