Nuformix plc (LON:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, is pleased to provide an update on progress with NXP002, the Company’s lead programme and a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis (PPF) and other progressive fibrosing interstitial lung diseases (ILDs).
Following the placing announced on 11 March 2026, the Company 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 is pleased to report 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;
· 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 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.
Dr Dan Gooding, Executive Director of Nuformix, said:
“We are very encouraged by these results, which significantly improve our understanding of how inhaled doses translate into pulmonary and systemic exposure, and into fibrosis-relevant biological activity for NXP002. Importantly, we have demonstrated that inhaled administration can achieve lung concentrations within the range expected to be therapeutically relevant based on our previous studies in human IPF lung tissue, alongside meaningful surrogate evidence of target/pathway engagement in vivo with direct relevance to the lung fibrosis phenotype.
“A key question arising through prospective partner discussions has been whether inhaled NXP002 can achieve exposures expected to provide efficacy while maintaining an appropriate safety margin. By combining our previous human lung tissue and preclinical data with the new pulmonary and systemic exposure data, we now have a significantly stronger basis from which to define that potential therapeutic window. This is particularly important for an inhaled treatment intended for chronic use and further strengthens our confidence in the development profile of NXP002.
“These findings provide an important bridge between the activity previously demonstrated in human lung tissue ex vivo, the exposures we can achieve following inhalation in vivo and evidence of engagement of fibrosis-relevant biology at those exposures. They also provide a stronger basis from which to plan the next stages of development.
“The programme was designed both to advance NXP002 and to address specific questions raised through our discussions with prospective partners. We believe these initial results achieve both objectives, and we look forward to sharing the data and continuing our partnering discussions at the forthcoming European Respiratory Society Congress, while additional mechanistic studies continue.”
