REG - Nuformix PLC - NXP004 Update

NuformixAnnouncement

20/12/2022 07:00

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RNS Number : 2214K  Nuformix PLC  20 December 2022

20 December 2022

 

Nuformix plc

 

("Nuformix" or the "Company")

 

NXP004 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 NXP004 programme,
focused on the development of novel, proprietary, cocrystal forms of olaparib,
a drug currently marketed by AstraZeneca, under the Lynparza® brand name.

 

Lynparza® is approved for treatment of an increasing number of cancers,
achieving sales of US$2.7bn in 2021 with industry analysts forecasting annual
sales of US$9.7bn by 2028. However, olaparib's very low aqueous solubility has
presented challenges historically in terms of "pill burden" and low olaprib
bioavailability with Lynparza® already having been reformulated once whilst
on market. In spite of reformulation, olaparib's bioavailability in the
currently marketed Lynparza® formulation remains unknown, but data indicate
low and variable drug exposure in humans.

The Company has filed two patent applications covering novel forms of olaparib
with the potential of protection out to 2041 and has previously demonstrated
the enhanced dissolution performance of all NXP004 cocrystals versus
crystalline olaparib drug substance.

Having identified two lead cocrystals for progression, the Company recently
announced commencement of work to scale-up production and directly compare
in-vitro dissolution performance of its lead cocrystals to the marketed
Lynparza® tablet product using a biologically relevant dissolution design and
with drug loading relevant to human dosing.

The Company is pleased to announce that the results from these studies
demonstrate that the two lead NXP004 cocrystals selected out-perform
Lynparza®, both in terms of rate and extent of dissolution and release of
olaparib.

Enhancement of dissolution in the currently marketed formulation of Lynparza®
resulted in improved bioavailability versus the initial marketed product.
Therefore, the NXP004 programme may offer potential to further increase
olaparib bioavailability. In addition, the potential simplicity of
NXP004-based formulations may offer improvements in product cost-of-goods
versus the currently marketed product, which requires complex manufacturing
methods.

These attributes position NXP004 for applications in line-extensions for the
currently marketed product, or for possible development in future
first-to-generic products.

The Company will now consider the design and execution of suitable
pre-clinical pharmacokinetic models to further investigate and validate
NXP004's potential for enhancing the oral absorption of olaparib. Securing
these data will enable commencement of discussions with multiple potential
commercialisation partners.

Further updates will be announced in due course, as appropriate.

Commenting, Dr Dan Gooding, Executive Director of Nuformix, said: "I'm
delighted with the results of the head-to-head dissolution studies, which
exceeded my expectations and have demonstrated first-time that the lead NXP004
cocrystals offer significant scope for enhanced performance versus Lynparza®,
for which biorelevant dissolution data is not in the public domain. The NXP004
cocrystals studied demonstrate some of the best dissolution performance I've
seen from application of the technology - a step-change in dissolution
performance, yet they appear to lack any of the common drawbacks that can
hamper development of cocrystal-based products, which is surprising. These new
data strongly support progression of the programme and we will now look to
translate these enhancements into an in-vivo setting, which if successful will
position the Company well for commencing partnering discussions with multiple
potential partners identified."

 

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 preclinical assets with potential
for significant value and early licensing opportunities.

 

 

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