Nuformix PLC NXP002 Update (2322U)
March 27 2023 - 2:00AM
UK Regulatory
TIDMNFX
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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