Nuformix (LSE:NFX) has reported further positive results on Monday from a pilot inhaled target engagement study of NXP002, its lead candidate for idiopathic pulmonary fibrosis (IPF), progressive pulmonary fibrosis and related interstitial lung diseases.
The London-listed pharmaceutical developer, which focuses on fibrosis and oncology through drug repurposing, said the study showed statistically significant modulation of TGF-β/SMAD signalling, a pathway central to pulmonary fibrosis progression.
NXP002 is an inhaled form of tranilast, a drug with an extensive history of oral clinical use and anti-fibrotic activity across multiple organ systems, which Nuformix is developing to exploit that pharmacology through direct lung delivery while avoiding the tolerability limits of chronic oral dosing.
Bleomycin challenge produced a substantial increase in the ratio of phosphorylated to total SMAD2/3, consistent with activation of pro-fibrotic signalling, while inhaled NXP002 reversed this at multiple timepoints across three dose levels tested.
The company said the response was most pronounced at the lowest dose studied, information it described as important for guiding dose selection in subsequent development work.
"We are extremely pleased with these results," said Dr Dan Gooding, Executive Director of Nuformix, adding that TGF-β signalling is central to fibrotic disease progression and that previous therapies targeting the pathway "have also highlighted the challenge of achieving an acceptable benefit-risk profile."
The new pSMAD/SMAD findings follow results reported in August from the same pilot study showing attenuation of bleomycin-induced alpha-smooth muscle actin expression across all doses tested, giving the programme two distinct biological readouts pointing to the same mechanism.
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Nuformix is convening an expert advisory board to review the NXP002 data package and guide prioritisation as the programme works towards IND-enabling studies, and has separately begun using a target discovery platform to probe further molecular targets behind the drug's anti-fibrotic activity.
The company said it held meetings with prospective development and licensing partners at the European Respiratory Society Congress in Barcelona last month, and that those discussions continue, supported by the latest results.
Nuformix reported a loss after tax of £346,577 and cash of £930,283 at its last half-year stage, to 31 March, and said it remains sufficiently capitalised to complete its currently planned development programme for NXP002.