Nanexa AB has announced positive results from its Phase I study of NEX-22, a novel once-monthly depot formulation of the GLP-1 analog liraglutide for the treatment of type 2 diabetes. The trial's success significantly bolsters Nanexa's prospects for securing licensing agreements and advancing the drug's development. The company is now focusing on finding a licensee for the Chinese market to fund further studies, with hopes of a US/EU license deal after the completion of Phase Ib/II trials.
The Phase I study, conducted in collaboration with Profil, a diabetes-focused CRO, met all primary and secondary endpoints. Key findings included dose linearity, a one-month pharmacokinetic profile, and the absence of significant adverse events, such as nausea or vomiting. Furthermore, minimal or no local reactions were observed, despite the administered dose being 17 times the normal daily dose of liraglutide. Liraglutide is currently marketed by Novo Nordisk as Victoza and Saxenda, both of which require daily injections.
Clinical Trial Details and Implications
The trial involved three dose-escalation cohorts of patients with type 2 diabetes. Subcutaneous administration of NEX-22 proved effective, suggesting the potential for improved patient adherence and reduced treatment discontinuation compared to existing daily GLP-1 products. The results mark the first clinical demonstration of a once-monthly GLP-1 product for diabetes patients.
Nanexa plans to initiate Phase Ib/II studies in Q3 2025, which will directly compare NEX-22 to Victoza. The company also intends to explore a 505(b)(2) regulatory pathway in the US, potentially expediting the approval process.
Strategic Focus and Future Development
Following a recent directed issue of units plus loan, raising a total of SEK 55m before costs, Nanexa is now less focused on achieving a regional license deal in Asia and is instead aiming to secure a global co-development deal for the continued development of NEX-22. With near-term financing secured into 2026, the company is optimistic about the future development of NEX-22 and its potential to address the unmet needs in type 2 diabetes management.
Management now targets the treatment of the first patient in phase Ib/II before year-end. This trial will be a direct pharmacokinetic comparison of NEX-22 to Victoza, where Nanexa will focus on similarity in order to build on Victoza’s original documentation. If successful, a Pre-IND with the FDA could be held by the end of 2025. After completing Phase III with some 300-400 patients, an application for NEX-22 could realistically be submitted in 2028, with a product on the market by 2029, some three years ahead of any competing long-acting Semaglutide drug. This timeline presents a highly attractive opportunity for potential licensees of NEX-22.
