REG - Nuformix PLC - NXP002 Update

NuformixAnnouncement

23/09/2022 07:00

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RNS Number : 3692A  Nuformix PLC  23 September 2022

23 September 2022

 

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").

 

2022 European Respiratory Society Congress ("ERS")

 

The Company recently presented NXP002 for the first time to the global IPF
medical and pharmaceutical specialist community at the ERS Congress in
Barcelona.  The Company's NXP002 poster sessions were well-attended by,
amongst others, potential licensing partners, while the conference confirmed
that inhalation is now widely accepted as a future IPF treatment modality.

 

In spite of their limited efficacy and poor side effect profile, existing
standard-of-care therapies (OFEV(®), Esbriet(®)) are not expected to be
displaced in the near future as emerging data relating to prevention of
exacerbations, now linked with mortality, are supportive of their continued
use.  Therefore, NXP002's clinical route to patients will be additive to
current standards-of-care.

 

As in cancer and other severe respiratory diseases, combination therapies are
likely to become the first-line treatment regimen in IPF.  NXP002
standard-of-care combinations will therefore now become the focus of the
Company's future NXP002 development activities, initially using 3D human
tissue models of IPF, to better align development with the growing preference
of licensing partners and regulators.

NXP002 remains a significant potential value driver for the Company given no
new therapies have been approved in IPF, the potential impact of COVID on
fibrotic lung disease, the progress of the NXP002 programme in discharging key
development risks and commercial intelligence obtained at ERS.  Furthermore,
the multiple clinical research publications emerging during 2022 studying the
acute use of oral tranilast in treating severe COVID patients' fibrosis are
highly supportive of NXP002's potential in treating IPF chronically via
inhalation.

Pre-Clinical Update

The pre-clinical inhalation strategy, initiated by the Company's previous
management, has significantly progressed the overall NXP002 programme:

o  tranilast, as NXP002, can be delivered in-vivo by a range of nebulisers at
the optimum particle size;

o  very high doses appear to be well-tolerated; and

o  an in-vivo dose response was observed for inflammatory and fibrotic
biomarkers following inhalation that is consistent with previous ex-vivo human
IPF tissue studies.

However, the pre-clinical inhalation disease model chosen has proven to be
complex, and unlike previous studies in human IPF tissue, it continues to be
challenging to achieve consistent and reproducible results, which will likely
increase in the study of combination therapies, which are now clearly required
given the clinical trends intelligence gathered at the ERS. As a consequence,
the Company is stopping its current study and will initiate studies in 3D
human IPF lung tissue using a disease and species relevant model that is now
available commercially via a CRO.  Work under this new strategy will start
immediately and focus on NXP002 in combination with current standards-of-care,
with the ultimate aim of reducing their negative side effects whilst enhancing
their efficacy.

 

NXP002 combinations have already shown great promise in human diseased IPF
tissue, showing a pleasing synergistic efficacy effect with low doses of
standards-of-care, resulting in the Group filing a new combination patent
application earlier in 2022. The change in pre-clinical strategy supported by
intelligence gathered at ERS is therefore aligned with and further enhances
the Company's overall patent position as it continues to build assets for
eventual out-licensing.

 

In addition to new work in human diseased IPF tissue, the Company will
evaluate NXP002 ex-vivo in healthy human lung tissue and human peripheral
blood mononuclear cells. These studies will be funded from the Company's
existing cash position and alongside further human IPF lung tissue studies,
will allow the Company to rapidly and cost-effectively investigate NXP002's
duration of action. With the exception of Investigational New Drug Application
enabling studies, these studies are expected to be the last non-clinical
studies conducted as the Company seeks to move NXP002 to the next stage of
development.

 

Results will continue to be generated throughout H2 2022 with further updates
announced in due course, as appropriate.

 

Commenting, Dr Dan Gooding, Executive Director of Nuformix, said: "Our first
attendance at ERS has introduced our lead programme to major respiratory
players, whilst generating valuable intelligence, allowing us to maintain and
develop our current market-orientated development strategy.  As a virtual
company, Nuformix can rapidly adapt its development strategy to align with
emerging trends. Fortunately, we are in a moment where those trends are
converging with our programme, our enhanced IP position and our access to a
new, close-to-patient, disease relevant model.  The prospect of increased
efficacy with improved quality of life for IPF patients is a realistic
possibility for NXP002 combination therapies based on our existing pilot human
IPF tissue data.  I am confident that our revised pre-clinical strategy will
maximise the value of our IP estate and will generate further compelling data
to support both progression and partnering of NXP002.  I look forward to
providing further updates throughout the remainder of the year."

 

 

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 pre-clinical 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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