TIDMNFX
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 (R) , Esbriet (R) ) 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 (R)
and Esbriet (R) achieved $2.58bn and $1.04bn respectively in
2021.
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