Nanexa includes first patient in PharmaShell study

31 May, 2021
- Press Release

Nanexa AB (publ) today announces that the company has included the first patient in its first clinical study with PharmaShell®. A phase I study in Nanexa's product project NEX-18.

The study aims to show that the company's NEX-18 product, a long-acting formulation of azacitidine (the active substance in the drug Vidaza), provides the desired safety and pharmacokinetic profile. The study studies two doses of NEX-18. The first patient was included at Karolinska University Hospital Huddinge.

“The inclusion of the first patient in the study is a very big milestone in our development. The patient in question has received an injection of NEX-18 and everything has gone well. I now look forward to including more patients so that we can complete the study during the third quarter,” said David Westberg, CEO of Nanexa.

The NEX-18 product is being developed to improve the treatment of MDS (Myelodysplastic Syndrome), a form of haematologic cancer that mainly affects the elderly. This is done by utilizing the unique properties of the PharmaShell® concept to create a controlled release depot formulation. Today's treatment means that injections are given at hospitals seven days in a row each month. The goal of the NEX-18 project is to simplify the treatment by only having to give one injection. In addition to greatly simplifying for patients, Nanexa sees that NEX-18 will provide significant cost savings compared to current treatment.

“With the results of this study, we intend to continue the clinical development with a phase Ib/II study to achieve clinical Proof of Concept. After that, the goal is to take NEX-18 towards commercialization, either together with a licensing partner or by ourselves, depending on what is judged to create the most value for Nanexa," said David Westberg.