Nanexa - NEX-18 study start

First-in-human trial with NEX-18 has now started Original timeline with Q3’21 results reiterated Positive for the share NEX-18 study start announced Nanexa announced this morning that its first clinical trial with lead candidate NEX-18 has now begun at one of its two clinical trial sites at the Karolinska University Hospital in Stockholm. The company announced earlier in April that the trial start at the second site in Uppsala had to be postponed due to the particularly strained COVID-19 situation in the region. The Ph Ia study of NEX-18 is Nanexa’s first trial of its PharmaShell® technology in patients. NEX-18 is a long-acting reformulation of azacitidine (the active compound in the drug Vidaza) used to treat MDS (myelodysplastic syndrome), a form of haematological cancer.

NEX-18 has been designed to be given as a once-monthly injection, instead of the seven daily hospital injections needed for existing forms of azacitidine. Readout expected in Q3’21 When the delayed trial start in Uppsala was announced earlier in April wording from management was that it was too early to be sure if it would impact the original readout expected in Q3’21. Nanexa management today sound more confident and stated that the study should be completed during Q3’21, as originally planned.

With the Karolinska University Hospital having dropped down from its state of readiness on 27/4 it is possible that more of the study could end up being run at this site. Positive for the share Although the study start at the Karolinska site was expected by late April, we view the statement from management that the study should finish during Q3’21 as positive. The first-in-human trial of the PharmaShell® technology is an important milestone that could raise interest among potential technology licensors who are likely waiting for first safety data in humans and clinical proof-of-concept data.

Assuming positive results from the Ph I study, Nanexa plan to move NEX-18 into a Ph Ib/IIa PoC study in H.