Nuformix plc (LSE:NFX) has reported further preclinical findings for NXP002, its investigational inhaled treatment for idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis and related interstitial lung diseases.
The company’s latest pilot inhaled target engagement study found statistically significant changes in the TGF-β/SMAD signalling pathway, which is involved in the development and progression of pulmonary fibrosis.
Nuformix said the study showed suppression of the phosphorylated SMAD-to-total SMAD (pSMAD/SMAD) ratio, including at the lowest dose tested. Significant reductions were observed across multiple doses and timepoints.
The results add to earlier α-smooth muscle actin (α-SMA) biomarker findings and form part of the company’s ongoing investigation into the biological activity of NXP002.
The findings are preclinical and do not establish clinical efficacy or safety in patients.
Study Examines NXP002’s Effect on Fibrosis-Related Signalling
The pilot study evaluated whether inhaled NXP002 could affect activity in the TGF-β/SMAD signalling pathway.
Nuformix reported statistically significant suppression of the pSMAD/SMAD ratio at several dose levels and measurement points, including at the lowest dose tested.
The company is investigating this pathway because of its involvement in fibrotic processes in the lungs.
The latest results complement earlier α-SMA biomarker data, which also formed part of the programme’s assessment of fibrosis-related biological activity.
Nuformix said the combined findings, alongside previously reported exposure data, are being used to inform the selection of biologically relevant dose ranges for further development.
The supplied update does not disclose the study’s sample size, numerical effect sizes or detailed statistical results.
NXP002 Development Moves Towards IND-Enabling Studies
Nuformix is convening an expert advisory board to help guide the next stage of NXP002’s development.
The company intends to advance the programme towards investigational new drug (IND)-enabling studies, which would support preparation for potential clinical testing.
NXP002 is an inhaled formulation of tranilast, being developed for IPF, progressive pulmonary fibrosis and other progressive fibrosing interstitial lung diseases.
The programme is intended to investigate whether delivering tranilast through inhalation can provide lung-targeted exposure for the treatment of fibrotic lung conditions.
Nuformix has also begun work with a target discovery platform to investigate additional molecular targets that may contribute to NXP002’s anti-fibrotic activity.
The research is intended to broaden the company’s understanding of the candidate’s mechanisms of action and assess whether it affects multiple pathways associated with fibrosis.
Partnering Discussions Continue Following Respiratory Congress Meetings
Nuformix said it held meetings with prospective development and licensing partners at the European Respiratory Society Congress.
The company described the discussions as encouraging and said the additional preclinical findings would contribute to its ongoing partnering activities.
The programme’s development rationale is based on its preclinical exposure, biomarker and pathway data, together with further work to investigate its biological effects.
Nuformix said it has sufficient capital to complete its current programme of work.
The company has not announced a licensing agreement or disclosed financial terms for any potential partnership.
Further Research Required to Establish Clinical Potential
NXP002 remains at the preclinical development stage. The latest study provides evidence of modulation of a fibrosis-related signalling pathway, but further research will be needed to assess the candidate’s safety, efficacy and suitability for clinical development.
Nuformix plans to use the new findings, previous exposure data and input from its expert advisory board to inform the next phase of the programme.
The company’s ongoing work includes investigating additional molecular targets, refining dose selection and progressing towards IND-enabling studies.
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