REG - Nuformix PLC - Positive pre-clinical data on NXP002

NuformixAnnouncement

25/11/2021 07:00

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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 (http://www.nuformix.com/)
.

 

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