Nuformix PLC Positive pre-clinical data on NXP002 (5045T)
November 25 2021 - 1:59AM
UK Regulatory
TIDMNFX
RNS Number : 5045T
Nuformix PLC
25 November 2021
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Nuformix plc
("Nuformix" or the "Company")
Positive pre-clinical data on NXP002
Nuformix plc (LSE: NFX), a pharmaceutical development company
targeting unmet medical needs in fibrosis and oncology via drug
repurposing, provides an update on its lead asset, NXP002, which it
is currently developing as a potential novel treatment for
Idiopathic Pulmonary Fibrosis ("IPF"). This update comes as a
result of positive data received following initial pre-clinical
studies.
NXP002 is a repurposed, new form of tranilast, that the Company
is developing in an inhaled formulation for direct delivery to the
lungs. Nuformix has successfully performed a number of pre-clinical
studies as planned to generate a robust data package. The studies
completed of the data package thus far comprise of:
- in vitro studies to demonstrate that NXP002 can be formulated
in a formulation suitable for inhaled delivery by nebulisation;
and
- in vivo studies to look at the pharmacokinetics and
pharmacodynamics of NXP002 in a pre-clinical species when
inhaled.
The in vitro studies demonstrated that it is feasible to
formulate NXP002 into a simple and stable solution which has
suitable properties for delivery via nebulisation. The data
generated on these formulations also show that the drug can be
efficiently delivered in the right particle size range for lung
delivery using off-the-shelf and commonly used nebuliser devices.
Thus, Nuformix believes that the delivery of NXP002 by nebulisation
is feasible.
The first of the in vivo studies evaluated the pharmacokinetics
of NXP002 when delivered by nebulisation to rats. This study
demonstrated that NXP002 can be efficiently delivered to the lung,
achieving significant drug levels, whilst limiting systemic
exposure compared to oral dosing.
The second in vivo study evaluated the pharmacodynamics of
NXP002 when delivered by nebulisation. This study showed that
inhaled NXP002 could dose-dependently regulate the production of
fibrosis-relevant mediators.
The final planned study as part of the NXP002 pre-clinical data
package is an in vivo study investigating the durability of the
pharmacodynamic effect. The Company anticipates receiving the data
for this study in early 2022.
Dr Anne Brindley, CEO of Nuformix, said: "We're delighted with
the positive readout of this data so far and it further cements our
belief in NXP002 as a valuable asset. Tranilast is poorly soluble,
meaning it is not well absorbed into the body and tissues, and it
also has issues regarding systemic toxicity. NXP002 is a new form
of tranilast that shows greater solubility than the original drug,
allowing it to be delivered to the lungs that are the site of
action for IPF. By delivering directly to the lungs, we anticipate
that a lower dose will be required to produce a pharmacological and
therapeutic effect with reduced systemic toxicity compared to oral
dosing.
" We have previously reported data on the activity of NXP002 in
human IPF lung slices in vitro, and the in vivo results to date are
consistent with these data, both in terms of mediators modulated
and the exposure required to achieve this modulation. The data
generated to date provide a robust translational package and
support the further progression of this asset. Further studies are
ongoing to assess the durability of the pharmacodynamic effect and
we look forward to updating the market in due course."
Enquiries:
Nuformix plc via Walbrook
Dr Alastair Riddell, Non-Executive
Chairman
Dr Anne Brindley, CEO
Allenby Capital Limited +44 (0) 20 3328 5656
Nick Athanas / George Payne (Corporate
Finance)
Stefano Aquilino / Matt Butlin (Sales
and Corporate Broking)
Walbrook PR nuformix@walbrookpr.com or +44 (0)20
7933 8780
Anna Dunphy / Phillip Marriage Tel: +44 (0)7876 741 001 / +44
(0)7867 984 082
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 an early-stage pipeline of preclinical
and Phase 1-ready assets with potential for significant value and
early licensing opportunities.
About NXP002
NXP002 is a new form of tranilast being developed as an inhaled
product for the treatment of Idiopathic Pulmonary Fibrosis, a
devastating lung disease with a high mortality rate. NXP002 is
being developed for delivery direct to the lungs by inhalation, a
new route of administration for this drug. This new form of
tranilast is significantly more soluble than tranilast and thus
lends itself well to a solution formulation for delivery by
inhalation. The inhalation route is a well-known strategy for
treatment of lung diseases to yield greater efficacy and reduce
systemic side-effects compared to oral treatment. This is due to
the fact that the dose required for activity when delivered by
inhalation is usually a fraction of that required by oral delivery
to give the same effect. This approach has potential to reduce the
required dose of drug compared to orally delivered tranilast and to
reduce systemic side effects.
For more information, please visit www.nuformix.com .
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