REG - Nuformix PLC - Corporate Update

NuformixAnnouncement

30/05/2022 07:15

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RNS Number : 1592N  Nuformix PLC  30 May 2022

30 May 2022

 

Nuformix plc

 

("Nuformix" or the "Company")

 

Corporate Update

 

Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet
medical needs in fibrosis and oncology via drug repurposing, is now able to
provide an update on the Company's assets and other corporate matters.

 

NXP002

 

NXP002, a new form of tranilast, is the Company's pre-clinical lead asset and
a potential novel inhaled treatment for Idiopathic Pulmonary Fibrosis ("IPF").

 

As announced on 25 November 2021, positive data was received from initial
pre-clinical studies.  In vitro studies demonstrated NXP002's feasibility for
formulation as a simple and stable solution with suitable properties for
delivery via nebulisation.

 

In vivo studies evaluated NXP002's pharmacokinetics when delivered by
nebulisation. Results demonstrated that NXP002 can be efficiently delivered to
the lung.

 

Further in vivo studies evaluated the pharmacodynamics of NXP002 when
delivered by nebulisation. This study showed that inhaled NXP002 could
dose-dependently regulate the production of inflammation and fibrosis-relevant
cell mediators in response to a lipopolysaccharide ("LPS") challenge.

 

Following the results of these studies, a final planned pre-clinical study was
commissioned to assess the duration of action with the gap between inhaled
NXP002 and the LPS challenge extending from 30 minutes, as in the first study,
in various stages up to eight hours.  However, the Contract Research
Organisation ("CRO") undertaking the study had a protocol failure, voiding the
study. The CRO repeated the study as per the protocol.

 

The repeat study has recently concluded. The results, however, were
inconsistent with the first in vivo study at all time points and also with the
oral control.  In the opinion of the Company and its development advisers, no
positive or negative conclusions could be drawn from this study.

 

The Company, in consultation with the CRO, has therefore decided to move
forward with further studies, including evaluation of a new formulation.  New
studies will examine both the pharmacokinetics of NXP002 as an inhaled product
and further test its efficacy in repeat LPS challenge studies.  The timing of
results from this study is dependent upon the availability of slots with the
CRO and is expected on or before Q1 2023.

 

NXP004

 

The Company has previously demonstrated the enhanced performance of NXP004
compared to olaparib's free form.  Subsequently, additional pre-formulation
studies have been completed confirming the superiority of the Company's
recently patented cocrystal forms and a lead cocrystal has been selected to
enter drug product development.  Further updates will be announced in due
course.

 

NXP001

 

Following the Company's signing of an exclusive global licensing agreement
with Oxilio Ltd ("Oxilio") for NXP001 on 13 September 2021, Oxilio continues
to progress this asset.  NXP001 is a proprietary new form of aprepitant which
is currently marketed for cancer chemotherapy induced nausea and vomiting.
The arrangement with Oxilio is allowing them to progress NXP001 without cost
to the Company and Nuformix expects to receive milestone payments when the
product completes clinical trials and ultimately royalties on any sales.

 

The board believes the Company has sufficient funds to undertake the planned
studies on NXP002 and operate on current projections until Q4 2023.

 

Management

 

Following a search for a new Chief Executive Officer for the Company,
utilising external consultants, no suitable candidate has been identified.

 

Commenting, Alastair Riddell, Executive Chairman of Nuformix, said: "We
continue to believe that NXP002 is a valuable asset that can overcome the
limitations and issues of tranilast being delivered orally.  The further
study, that we anticipate will confirm the previous findings, will commence as
soon as the CRO is able.  We anticipate results from these studies by Q1
2023.  We have sufficient funds to conduct the studies on NXP002 and, based
on our current projections, to continue to Q4 2023."

 

Enquiries:

 

 Nuformix plc
 Dr Alastair Riddell, Executive Chairman           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 preclinical assets with potential
for significant value and early licensing opportunities.

 

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