Nuformix has reported positive preclinical results for NXP002, its inhaled treatment candidate for fibrotic lung diseases, strengthening the data package around the programme ahead of further development and licensing discussions.
The study examined how NXP002 performs when delivered directly to the lungs by inhalation. It found that the drug could be successfully formulated and nebulised across a broad range of concentrations and doses.
Importantly, lung exposure increased with dose. The concentrations achieved were within the range that earlier studies using human idiopathic pulmonary fibrosis lung tissue suggested could produce pharmacological activity.
This gives Nuformix clearer evidence that inhaled NXP002 can reach potentially useful concentrations in the lungs while allowing systemic exposure to be measured at the same time. That is an important development consideration for a treatment designed to act primarily in lung tissue.
The results also showed reduced expression of alpha-smooth muscle actin across all doses tested. This biomarker is associated with activated myofibroblasts, cells involved in the development of fibrosis. Nuformix considers the result evidence that NXP002 is engaging relevant fibrotic biology after inhaled administration.
The new study builds on earlier work carried out using diseased human lung tissue. Nuformix can now combine those findings with in vivo data showing how much drug reaches the lungs and how biological markers respond after treatment.
That combination strengthens the basis for deciding what dose levels should be taken into further preclinical studies. It also gives the company more information to assess the potential balance between local lung activity and systemic exposure.
Nuformix plans to use the results to support further preclinical development, including non-GLP dose-range-finding studies. Work is also continuing to investigate the biological targets and pathways responsible for NXP002’s anti-fibrotic effects.
These next studies will be important because NXP002 remains a preclinical programme. The latest results improve understanding of dose, exposure and biological activity, but additional development work will still be required before the drug can progress towards clinical testing.
Nuformix plc (LON:NFX) is a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology using drug repurposing.
