RE: NPX002 - lead asset27 Jan 2025 19:10
The Group's pre-clinical inhalation development strategy has significantly progressed NXP002 towards validation of its Target Product Profile ("TPP") demonstrating:
• NXP002 can be delivered in-vivo by a range of nebulisers at the optimum particle size for delivery to the deep lung;
• high doses appear to be well-tolerated; and
• an in-vivo inhalation dose response was observed for inflammatory and fibrotic biomarkers that is consistent with ex-vivo human IPF tissue studies to date.
The Group conducted studies in a new iteration of a 3D human IPF lung tissue using a disease and species relevant model that has been advanced to significantly reduce output variability. The results from these studies of NXP002 alone and in combination with current SoCs, can be summarised as follows:
• NXP002 is well tolerated in ex-vivo human lung tissue with no signs of toxicity events;
• NXP002 alone delivers a strong, consistent anti-fibrotic and anti-inflammatory effect as demonstrated by modulation of the release of multiple biomarkers of fibrosis and inflammation;
• both high and low concentrations of NXP002 show an additive anti-fibrotic and anti-inflammatory effect to SoC;
• in particular, the higher concentrations of NXP002 with SoC's deliver a near complete ablation of fibrosis biomarker release, yet at lower concentrations than have been seen in other preclinical models to date; and
• the clear, pronounced additive benefit of NXP002 on top of SoCs observed suggests that NXP002 may provide additional efficacy, even in patients responding to SoC therapy.
This raises the possibility that NXP002 targets additional disease pathways to SoC's when increasing the combined anti-fibrotic and anti-inflammatory response. Following success in suppressing biomarkers of fibrotic disease progression in human IPF lung tissue, the same samples were analysed to assess additional mechanistic and anti-inflammatory benefits on top of SoC's and the results are summarised as follows:
• NXP002 alone delivers a strong, consistent anti-inflammatory effect as demonstrated by suppression of the release of inflammatory cytokines by over 90% for all cytokines studied; and
• the results further suggest that NXP002 may provide additional efficacy in combination with SoC's, even in patients not responding to SoC therapy alone.
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