Nanexa pauses NEX-18 study

24 September, 2021
- Regulatory

Nanexa today announces that the inclusion of patients in the company's phase I study with NEX-18, a depot formulation of 5-azacitidine, is paused due to moderate skin reactions at the injection site.

The moderate skin reactions that have occured differ slightly from the mild reaction that normally occurs after the administration of 5-azacitidine. To clarify the cause, Nanexa together with the clinics is conducting an investigation including biopsies of the affected skin. The investigation is expected to be concluded in Q4 2021.

“The pause in inclusion is done with the patients' best interests in mind. We will return as soon as we have more information about what caused these moderate skin reactions and about how we proceed with the study," said Nanexa's CEO David Westberg.

The study preliminarily shows that PharmaShell works as expected when it comes to creating a beneficial pharmacokinetic profile, which is in line with what has been shown in the preclinical studies. The interruption has no effect on the planning and preparation of Nanexa's other clinical project, NEX-20, with lenalidomide in multiple myeloma, or on ongoing partner activities. The work of selecting the next drug candidate for NEX-21 is also proceeding according to plan.