Nuformix Regulatory News (NFX)

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."

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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.