Nanexa has completed the planned recruitment to the Phase 1 study of NEX-20
Nanexa AB today announced that the recruitment and dosing has been completed in the NEX-20 Phase 1 study. Since December last year, healthy volunteers have been administered single doses in three sequential escalating dose groups. Data on the pharmacokinetic profile, safety and tolerability is now being collected for the last dose group, and results are expected to be presented after the summer.
“We are very happy to have completed the recruitment on time and we look forward to evaluating study results of NEX-20” says David Westberg, CEO of Nanexa. “I am very proud of our project team dedicated to deliver this study according to target timelines and generate high quality data for us to take the next step in the NEX-20 project. We know from discussions with our international advisory board that adherence to the prescribed treatment with lenalidomide can be suboptimal for some patients, and as more and more patients globally are treated with lenalidomide for a long time, we clearly see that there is an unmet medical need where we can help by providing a depot formulation like NEX-20.”
NEX-20 is a long-acting formulation of lenalidomide based on Nanexa’s drug delivery system PharmaShell®. Lenalidomide is an immunomodulatory compound targeting both cancer cells and their microenvironment (1). Currently patients take lenalidomide daily as an oral capsule for 21-28 days in 28-day cycles.
1) A review of the history, properties, and use of the immunomodulatory compound lenalidomide Zeldis et al. Ann NY Acad Sci. 2011 Mar;1222:76-82