Nuformix PLC NXP004 Update (2214K)
20 Décembre 2022 - 8:00AM
UK Regulatory
TIDMNFX
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(R) brand name.
Lynparza(R) 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(R) already having been reformulated once whilst on market.
In spite of reformulation, olaparib's bioavailability in the
currently marketed Lynparza(R) 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(R) 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 (R), both in terms of rate and extent of
dissolution and release of olaparib.
Enhancement of dissolution in the currently marketed formulation
of Lynparza (R) 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 (R) ,
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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