Nanexa expands Phase I study with NEX-22 with an additional dose group

Nanexa AB announces that the phase I study with NEX-22, the company’s one-month formulation of liraglutide, will resume with further dose escalation with an expected start in the first quarter of 2025. The study will now continue to include patients after receiving regulatory approval to add a dose group for the administration of 30 mg liraglutide.

The study is being conducted, as before, in patients with type 2 diabetes who have not previously been treated with GLP-1 drugs, at Profil, a world-leading diabetes CRO in Germany. As announced in November, the study has completed three cohorts with escalating doses up to 10 mg in order to assess the pharmacokinetic profile, safety and tolerability of different dose levels. The depot formulation NEX-22 is administered as an injection under the skin (subcutaneously). Results from a fourth cohort are expected in the second quarter of 2025.

"Adding an additional dose group gives us an opportunity to already now study a formulation of NEX-22 in a significantly higher dose. This additional dose escalation will give us an even better foundation for the next phase Ib/II study and further development of NEX-22", says David Westberg, CEO of Nanexa.

Datum 2025-01-28, kl 08:30
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