Nuformix Regulatory News (NFX)

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Nuformix plc

("Nuformix" or the "Company")

Positive pre-clinical data on NXP002

Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, provides an update on its lead asset, NXP002, which it is currently developing as a potential novel treatment for Idiopathic Pulmonary Fibrosis ("IPF"). This update comes as a result of positive data received following initial pre-clinical studies.

NXP002 is a repurposed, new form of tranilast, that the Company is developing in an inhaled formulation for direct delivery to the lungs. Nuformix has successfully performed a number of pre-clinical studies as planned to generate a robust data package. The studies completed of the data package thus far comprise of:

- in vitro studies to demonstrate that NXP002 can be formulated in a formulation suitable for inhaled delivery by nebulisation; and

- in vivo studies to look at the pharmacokinetics and pharmacodynamics of NXP002 in a pre-clinical species when inhaled.

The in vitro studies demonstrated that it is feasible to formulate NXP002 into a simple and stable solution which has suitable properties for delivery via nebulisation. The data generated on these formulations also show that the drug can be efficiently delivered in the right particle size range for lung delivery using off-the-shelf and commonly used nebuliser devices. Thus, Nuformix believes that the delivery of NXP002 by nebulisation is feasible.

The first of the in vivo studies evaluated the pharmacokinetics of NXP002 when delivered by nebulisation to rats. This study demonstrated that NXP002 can be efficiently delivered to the lung, achieving significant drug levels, whilst limiting systemic exposure compared to oral dosing.

The second in vivo study evaluated the pharmacodynamics of NXP002 when delivered by nebulisation. This study showed that inhaled NXP002 could dose-dependently regulate the production of fibrosis-relevant mediators.

The final planned study as part of the NXP002 pre-clinical data package is an in vivo study investigating the durability of the pharmacodynamic effect. The Company anticipates receiving the data for this study in early 2022.

Dr Anne Brindley, CEO of Nuformix, said: "We're delighted with the positive readout of this data so far and it further cements our belief in NXP002 as a valuable asset. Tranilast is poorly soluble, meaning it is not well absorbed into the body and tissues, and it also has issues regarding systemic toxicity. NXP002 is a new form of tranilast that shows greater solubility than the original drug, allowing it to be delivered to the lungs that are the site of action for IPF. By delivering directly to the lungs, we anticipate that a lower dose will be required to produce a pharmacological and therapeutic effect with reduced systemic toxicity compared to oral dosing.

"We have previously reported data on the activity of NXP002 in human IPF lung slices in vitro, and the in vivo results to date are consistent with these data, both in terms of mediators modulated and the exposure required to achieve this modulation. The data generated to date provide a robust translational package and support the further progression of this asset. Further studies are ongoing to assess the durability of the pharmacodynamic effect and we look forward to updating the market in due course."

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About Nuformix

Nuformix is a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing. The Company aims to use its expertise in discovering, developing and patenting novel drug forms, with improved physical properties, to develop new products in new indications that are, importantly, differentiated from the original (by way of dosage, delivery route or presentation), thus creating new and attractive commercial opportunities. Nuformix has an early-stage pipeline of preclinical and Phase 1-ready assets with potential for significant value and early licensing opportunities.

About NXP002

NXP002 is a new form of tranilast being developed as an inhaled product for the treatment of Idiopathic Pulmonary Fibrosis, a devastating lung disease with a high mortality rate. NXP002 is being developed for delivery direct to the lungs by inhalation, a new route of administration for this drug. This new form of tranilast is significantly more soluble than tranilast and thus lends itself well to a solution formulation for delivery by inhalation. The inhalation route is a well-known strategy for treatment of lung diseases to yield greater efficacy and reduce systemic side-effects compared to oral treatment. This is due to the fact that the dose required for activity when delivered by inhalation is usually a fraction of that required by oral delivery to give the same effect. This approach has potential to reduce the required dose of drug compared to orally delivered tranilast and to reduce systemic side effects.

For more information, please visit www.nuformix.com.