Nuformix Regulatory News (NFX)

18 May 2023

Nuformix plc

("Nuformix" or the "Company" or the "Group")

NXP002 - Inflammation and Duration of Action Update

Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, is pleased to announce the following update regarding the Company's NXP002 programme, a proprietary new form of tranilast, being developed as a novel inhaled treatment for Idiopathic Pulmonary Fibrosis ("IPF").

The Company recently announced that it was undertaking studies measuring NXP002's modulation of inflammation-related biomarkers alone and in combination with current IPF standards of care ("SoC") in a novel 3D human IPF lung tissue model, in addition to the use of an exploratory healthy human lung tissue model to investigate NXP002's duration of action. The study results are described below.

Inflammation

Following success in supressing 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;

· Both high and low concentrations of NXP002 show an additional anti-inflammatory effect in the presence of SoC's and enhance their anti-inflammatory performance;

· This effect is most pronounced for MCP-1, which is most closely linked with the progression of IPF

· The results further suggests that NXP002 will provide additional efficacy in combination with SoC's, even in patients responding to SoC therapy alone. The data also continues to support the possibility that NXP002 targets additional disease pathways to SoC's, increasing the combined anti-fibrotic and anti-inflammatory responses.

Overall, the results strengthen NXP002's potential to increase efficacy of existing therapies with the benefits of inhaled delivery (e.g. added efficacy without increased side effects). They also support NXP002's potential as a monotherapy for patients non-responsive to SoCs and those declining these therapies due to side effects which impact quality of life.

Duration of Action

Demonstration of a prolonged duration of action is essential in the development of inhaled therapies, whose clearance from the lung can be rapid. Therapies requiring multiple (more than two) daily uses of inhalation devices for effective treatment are less attractive and suffer reduced patient compliance, even in life-threatening conditions such as IPF. Therefore, Nuformix has developed a Target Product Profile that is consistent with twice daily inhalation administration.

In order to assess NXP002's duration of action, the Company initiated work in an exploratory LPS challenge model in healthy human lung tissue, which offers numerous advantages in terms of species relevance and the ability to control tissue exposure to drug. The model also bridges the Company's successful pre-clinical work across a variety of LPS-challenge studies. The results are summarised as follows:

· NXP002 suppresses the release of inflammatory cytokines by healthy human lung tissue following LPS challenge;

· This effect is seen at one hour post treatment with NXP002, suggesting only a short time is required for lung tissue penetration and activity;

· A strong anti-inflammatory effect remains at 12 hours post drug dosing demonstrated by suppression of the release of inflammatory cytokines following LPS challenge, confirming NXP002 has a suitable duration of action; and

· An anti-inflammatory effect is still observed at 24 hours post removal of drug.

Next Steps

Following the success achieved in these studies the Company's next steps include:

· Expansion of the current studies to include tissue from further human IPF tissue donors to demonstrate the robustness of NXP002's anti-fibrotic response alone and in SoC combinations in multiple patients; and

· Formally commencing the NXP002 partnering process now that Company has the minimum dataset required to support NXP002's development as an inhaled treatment for IPF, for use alongside SoC's.

Further updates will be announced in due course when appropriate.

Commenting, Dr Dan Gooding, Executive Director of Nuformix, said: "I'm absolutely delighted with the data we've generated over recent months - all the results we've achieved are as good as we could have hoped for and are the first results from advanced 'close to patient' IPF and inflammation human tissue disease models. The inflammation data was perhaps expected given past results but provides further support of NXP002's potential to deliver increased performance on top of existing standards of care. However, the positive duration of action data is a first for the NXP002 programme and allows the Company to discharge one of the programme's last remaining development risks that hasn't previously been addressed.

"The combined data gives us great confidence in NXP002's potential as an inhaled therapy for IPF treatment and allows the Company to tell a more complete pre-clinical story to potential licensing partners for the first time. We will now look for opportunities to share this important new data with key players in the rare disease and respiratory disease sectors as we explore all opportunities to progress the NXP002 programme."

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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 a pipeline of preclinical assets with potential for significant value and early licensing opportunities.

About Fibrosis

Fibrotic disease is typically associated with high patient mortality, increasing prevalence and a lack of safe and effective treatments. Whilst fibrosis treatments are in their infancy the emerging lung fibrosis market demonstrates their blockbuster potential. Idiopathic Pulmonary Fibrosis is classified as a rare disease and presents a global commercial market that is forecast to grow to $5bn by 2025. Sales of standard-of-care therapies OFEV and Esbriet achieved $2.58bn and $1.04bn respectively in 2021.