Nuformix plc (LON:NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, has provided an update in relation to the Company’s NXP004 programme, focused on the development of novel physical forms of olaparib. Olaparib is currently marketed by AstraZeneca, under the Lynparza® brand name. Lynparza® was first approved in December 2014 for the treatment of adults with advanced ovarian cancer and deleterious or suspected deleterious germline BRCA mutation. Since then, Lynparza® has secured similar approvals in breast, pancreatic and prostate cancers with further trials on-going. These approvals have propelled Lynparza® sales to US$2.7bn in 2021, with industry analysts forecasting annual sales of US$9.7bn by 2028.
Olaparib is known to present significant challenges in achieving effective oral delivery. In August 2017, AstraZeneca secured approval for a new formulation of Lynparza® which sought to address such challenges. The Company has previously demonstrated the enhanced performance of NXP004 cocrystals compared to olaparib. Further preformulation studies have allowed the Company to identify lead cocrystals from its patent estate to be progressed for further development.
The Company is pleased to report that it has initiated a programme of work to progress the NXP004 programme in three key areas:
· Commence the scale-up of lead cocrystal production processes;
· Directly compare in-vitro dissolution performance of lead co-crystals to the marketed Lynparza® product; and
· Based on the results from these studies a formulation development programme may be initiated. The aims of this work will be to develop prototype formulations that offer the potential to be both bioequivalent and ‘bio-better’ versus the Lynparza® product.
Further updates will be announced in due course, as appropriate.
Commenting, Dr Julian Gilbert, Non-executive Director of Nuformix, said: “The strategy of the Group is to continue to optimise value from its existing assets while maintaining tight control of costs. We believe that NXP004 has considerable commercial potential and the work we are now undertaking is designed to formulate our lead co-crystals towards a product form suitable for human use. This work will direct and support future out-licensing discussions for NXP004. I look forward to providing further updates in due course as we progress.”
