Nuformix plc (LON: NFX) has reported positive preclinical results for NXP002, its potential inhaled treatment for idiopathic pulmonary fibrosis and other progressive fibrosing lung diseases.
The latest study demonstrated that NXP002 can be successfully nebulised across a broad dose range and achieved substantial, dose-related exposure within the lungs.
Importantly, lung concentrations reached levels that Nuformix believes could provide therapeutic activity based on earlier studies using human IPF lung tissue, while systemic exposure remained at levels supporting the company’s modelling of a potential therapeutic dose.
The study has:
· confirmed the ability to formulate and successfully nebulise NXP002 across a broad concentration and inhaled dose range, including concentrations significantly above those expected to be required clinically;
· demonstrated substantial, dose-related pulmonary exposure of NXP002 across the inhaled dose range studied;
· achieved local lung concentrations of NXP002 within the range expected to provide pharmacological activity based on the Company’s previous studies in human IPF precision-cut lung slices (“PCLS”), while generating pulmonary and systemic exposure data that support the Company’s modelling of a potential therapeutic dose of inhaled NXP002;
· in addition, it is anticipated that the achieved lung exposures will be sufficient to support pivotal IND-enabling studies; and
· demonstrated attenuation of bleomycin-induced expression of alpha-smooth muscle actin (“α-SMA”) following NXP002 treatment across all doses studied. α-SMA is a biomarker associated with activated myofibroblasts and the fibrotic lung phenotype, and the Company considers these findings to provide meaningful surrogate evidence of target/pathway engagement following inhaled administration in vivo.
The study also found that NXP002 reduced bleomycin-induced expression of alpha-smooth muscle actin across all doses tested. The biomarker is associated with activated myofibroblasts and the fibrotic lung phenotype, providing what Nuformix describes as meaningful surrogate evidence that the inhaled drug is engaging fibrosis-related biological pathways in vivo.
The findings help address a key question raised during discussions with prospective licensing and development partners: whether inhaled NXP002 can deliver potentially effective concentrations directly to the lungs while maintaining an appropriate systemic safety margin.
Nuformix said the results strengthen the case for progressing towards non-GLP dose-range-finding studies, while additional work examining NXP002’s specific anti-fibrotic mechanisms remains underway.
The company will present updates on the programme and continue partnering discussions at the European Respiratory Society Congress in Barcelona in September.
