REG - Nuformix PLC - NXP002 Update

NuformixAnnouncement

27/03/2023 07:00

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RNS Number : 2322U  Nuformix PLC  27 March 2023

27 March 2023

 

Nuformix plc

 

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

 

NXP002 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 the commencement of studies using a new
iteration of a 3D human IPF lung tissue model - a high-challenge, disease and
species relevant pre-clinical model with its partner, Fibrofind.
 Advancements within this model were designed to significantly reduce output
variability.  The Company has now received results from these studies of
NXP002 alone and in combination with current standards of care ("SoC"), and
they 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 effect as
demonstrated by modulation of the release of multiple biomarkers of fibrosis;

·      Both high and low concentrations of NXP002 show an additive
anti-fibrotic 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 pre-clinical models to date; and

·    The clear, pronounced additive benefit of NXP002 on top of SoCs
observed suggests that NXP002 will 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 response.

 

Overall, the results provide further support of 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 declining SoCs - a meaningful
proportion of IPF patients who choose against the side effects of SoCs, which
impact quality of life.

 

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

 

·    Investigation of inflammation-related biomarkers in the same tissue
sample sets to confirm additional mechanistic and anti-inflammatory benefits
on top of SoC's, given the positive anti-fibrotic response;

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

·    To consider the expansion of the Company's on-going healthy lung
tissue study investigating NXP002's duration of action to three donors, based
on results when received.

 

Understanding the performance of new IPF therapies with SoC's has become
critical to both potential development partners and regulators.  Therefore,
the Company believes completion of these steps is required for Nuformix to
secure the interest of out-licensing partners.

 

Results will continue to be generated with further updates announced when
appropriate.

 

Commenting, Dr Dan Gooding, Executive Director of Nuformix, said: "All parties
are delighted with the results from this study, which are as good as we could
have hoped for and are the first results from what is the most advanced
iteration of this 'close to patient' IPF disease model to date.  The reduced
variability in the resulting data allows us to have high confidence in both
NXP002's anti-fibrotic activity alone, but also in the added anti-fibrotic
performance it can deliver on top of existing standards of care.  Additivity
to standard of care is the most important aspect because it's the simplest
option to investigate in a clinical study and is therefore fast becoming a top
priority for potential licensing partners.  Having seen the quality of these
results, our aim now is to generate datasets from three donors in both human
IPF and healthy lung duration of action studies.  These data can be generated
quickly and will be essential in opening up new discussions with potential
licensing partners and support overall progression of the NXP002 programme."

 

 

Enquiries:

 

 Nuformix plc
 Dr Dan Gooding, Executive Director                Via IFC Advisory

 Stanford Capital Partners Limited
 Tom Price / Patrick Claridge (Corporate Finance)  +44 (0) 20 3650 3650
 John Howes (Corporate Broking)                    +44 (0) 20 3650 3652

 IFC Advisory Limited
 Tim Metcalfe                                      +44 (0) 20 3934 6630

 Zach Cohen                                        nuformix@investor-focus.co.uk

 

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.

 

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