REG - Nuformix PLC - NXP002 Inflammation and Duration of Action Update

NuformixAnnouncement

18/05/2023 07:00

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RNS Number : 8021Z  Nuformix PLC  18 May 2023

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."

 

 

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 / Bob Pountney (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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