First patient dosed in Nanexa’s Phase I trial of NEX-22 in type 2 diabetes

11 June, 2024
- Press Release

Nanexa AB today announces that the company's Phase 1 study for type 2 diabetes has been initiated with dosing of the first patient. The study evaluates a long-acting depot formulation of the GLP-1 analog liraglutide with Nanexa's patented PharmaShell® system within the NEX-22 project. The study is a dose-escalation study aimed at evaluating the pharmacokinetic profile, safety and tolerability of different doses.

The study is being conducted in Germany by the CRO Profil and is the first clinical study to investigate a long-acting formulation of a GLP-1 compound based on PharmaShell. The study is an open-label phase 1 study where the long-acting formulation is administered by subcutaneous injection. The study is designed to include several consecutive groups with escalating doses. The study includes both women and men with type 2 diabetes. The results of the study will provide important information for optimization of the formulation for future regulatory pharmacokinetic and efficacy studies in patients with type 2 diabetes.

"This study is an important milestone for NEX-22 and Nanexa. A long-acting drug improves patient compliance and has the potential to increase efficacy and safety as well as reduce the environmental impact of single-use devices. We are pleased to partner with Profil, which has particular expertise in clinical trials in diabetes and obesity,” says Göran Ando, Chairman of the Board of Nanexa.

Glucagon-like peptide-1 (GLP-1) receptor agonists are a class of drugs for the treatment of type 2 diabetes and obesity. As the prevalence of obesity and type 2 diabetes increases worldwide, the market for GLP-1 receptor agonists is also growing. In a recent report, GlobalData estimates that sales of GLP-1 receptor agonists for the type 2 diabetes and obesity markets will reach over $125 billion by 2033 (1).

Nanexa believes that the increased convenience of fewer injections than current options makes its formulation an attractive treatment option for the majority of patients.

1. 68 market forecast för "Glucagon-Like Peptide-1 Receptor (GLP-1R) Agonists in Type 2 Diabetes and Obesity: 68-Market Analysis and Sales Forecast, Global Data, May 2024