Nuformix plc (LON:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, has announced results following the re-analysis of data from previous studies of NXP002 in a precision-cut lung slice (PCLS) disease model using tissue explanted from lung-transplant receiving patients with idiopathic pulmonary fibrosis (IPF) and autoimmune-related interstitial lung disease (ILD).
The data re-analysis undertaken was an outcome of on-going discussions with potential licensing and development partners for NXP002. In addition to patients with IPF and progressive pulmonary fibrosis (“PPF”), patients suffering from autoimmune ILDs (e.g. rheumatoid arthritis or systemic scleroderma) also have a high-mortality progressive fibrotic disease course which is not currently adequately treated.
In addition to lung tissue from seven IPF patients, NXP002 has been studied in tissue from an autoimmune ILD explanted lung (in this case from a patient diagnosed with non-specific interstitial pneumonia or NSIP). This data was revisited to compare key biomarker changes in tissue in response to NXP002 treatment using an ‘area under the curve’ (AUC) based approach, considering total biomarker expression during the treatment period. These new results are summarised as follows:
· A clear dose response to NXP002 was observed across both extra cellular matrix (“ECM”) biomarkers and pro-fibrotic mediators suggesting NXP002’s activity in additional pathways to standards of care;
· A consistent and significant effect of NXP002 was observed alone and in combination with standards of care across both biomarker types in all donors;
· When the Col1A1 gene was found to be overexpressed in tissue, representing active fibrotic disease and tissue turner, NXP002 consistently attenuates it’s expression. When Col1A1 is not overexpressed Col1A1 is maintained, which may point towards NXP002’s role in ECM homeostasis and supporting healthy tissue repair and regeneration, consistent with the evidence base describing positive results from clinical studies of tranilast in a range of fibrotic diseases; and
· The autoimmune-ILD donor studied also showed a significant response across both biomarker types alongside the seven IPF donors confirming that NXP002’s activity translates well to autoimmune-derived ILDs.
Dr Dan Gooding, Executive Director, Nuformix, said: “The PCLS lung tissue model has become the gold-standard disease model thanks to various close-to-patient benefits. We believe the dataset we have generated, in what we believe is one of the largest IPF patient tissue sample sets studied, gives us great confidence in NXP002. In what is a highly variable and heterogenous disease, to see such consistent activity across all donors towards pro-fibrotic mediators in both IPF and autoimmune ILD is impressive. The emergence of data supporting additional activity towards Col1A1 overexpression is exciting because this profile would be in contrast to high-potency, single target therapeutics, whose activity may negatively impact healthy tissue repair processes, leading to increased risk in long term use as observed in numerous recent IPF clinical studies. For patients with ILD’s of an autoimmune origin, given such patients’ background systemic therapies, an inhaled approach towards treatment would be highly advantageous in both development and treatment. We are excited by the results and continue discussions with potential partners, who also see advantages in NXP002 in terms of therapeutic optionality and future product positioning. I look forward to providing further updates in due course.”
