TIDMNFX
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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