Nuformix plc commenced a focused programme of additional preclinical studies designed both to generate data required to support the further development of NXP002 and to address specific questions arising from ongoing discussions with prospective development and licensing partners. The Company reported positive results from the first of these studies, an inhaled pharmacokinetic and target engagement study designed to assess pulmonary exposure, systemic exposure and evidence of engagement of fibrosis-relevant markers following administration of NXP002 by inhalation. 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; 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 ("a-SMA") following NXP002 treatment across all doses studied.
a-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 Company's therapeutic-window assessment incorporates its previous human PCLS and other preclinical data, together with known information relating to NXP002's exposure and tolerability. The new inhalation data further support the potential to achieve pharmacologically active concentrations of NXP002 within the lung while limiting systemic exposure, an important consideration for the development of NXP002 as a chronic inhaled treatment.
Together, these findings provide an important link between the Company's previously demonstrated activity of NXP002 in diseased human lung tissue ex vivo, the pulmonary exposures achieved following inhalation in vivo and evidence of engagement of fibrosis-relevant biology at those exposures. The results also provide additional information to support the further preclinical development of NXP002, including progression towards non-GLP dose-range-finding studies. Additional studies investigating the specific biological targets and pathways through which NXP002 exerts its anti-fibrotic activity are ongoing.
The Company intends to incorporate the new results into its ongoing business development activities and will be attending the forthcoming European Respiratory Society Congress being held in Barcelona, Spain, from 5 to 9 September 2026, to share updates on the NXP002 programme and continue discussions with prospective development and licensing partners.
