Nuformix Regulatory News (NFX)

Nuformix plc

("Nuformix" or "the Company")

Nuformix signs agreement with Quotient Clinical

to commence a pilot bioequivalence study for NXP001

Nuformix, the pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs, announces that it has signed an agreement with Quotient Clinical ('Quotient'), a leading provider of specialist drug development services, to conduct a pilot bioequivalence study for one of Nuformix' lead programmes, NXP001, based on a currently marketed treatment in the field of oncology supportive care.

Pharmaceutical cocrystals are re-engineered crystalline forms of small molecule drugs, in which a drug and excipient are crystallised together. Resulting cocrystals can offer a number of performance improvements, such as solubility and dissolution of otherwise poorly soluble drugs. Under the terms of the agreement, Quotient will use its Translational Pharmaceutics platform to evaluate bioequivalence for the NXP001 cocrystal product in healthy subjects.

Quotient's Translational Pharmaceutics® platform integrates formulation development and real-time adaptive GMP manufacturing with clinical research. In comparison to traditional outsourcing approaches, Quotient's Translational Pharmaceutics® platform dramatically accelerates drug product development timelines and significantly reduces development costs. Nuformix hopes to realise these benefits in its NXP001 programme, consistent with its strategy of accessing World-leading external expertise to advance key programmes.

Dr Dan Gooding, CEO, Nuformix plc, said: "The appointment of Quotient was not a difficult decision as its Translational Pharmaceutics platform is perfectly suited to our needs in this final stage of our NXP001 programme - we were very impressed with Quotient's overall approach versus alternative options. Demonstrating NXP001's bioequivalence to the currently marketed product opens up immediate global out-licensing opportunities for Nuformix, so we're very excited to commence the study and also evaluate the platform's potential for future Nuformix clinical programmes,"

John McDermott, Executive Director, Drug Product Optimisation, Quotient Clinical, said: "We are pleased to announce this new client agreement with Nuformix, whose cocrystal approach further broadens our experience in addressing bioavailability challenges for poorly soluble drugs. This program of work is an excellent illustration of how we can assist our emerging biopharma customers to rapidly validate novel drug delivery technologies and new product concepts."

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About Nuformix plc www.nuformix.com 

Nuformix is a pharmaceutical development company using its cocrystal technology to unlock the therapeutic potential of approved small molecule drugs. Nuformix' risk-mitigated development strategy has resulted in a pipeline of discoveries through which it has developed and patented novel cocrystal forms of approved small molecules, creating an IP portfolio containing a range of granted patents covering cocrystal forms of five small molecule drugs. Nuformix is targeting high-value unmet needs with its lead programmes in oncology supportive care: NXP001 and fibrosis: NXP002.

Nuformix was established in Cambridge in 2008 and has invested into pharmaceutical cocrystal R&D, establishing world-class capability and know-how in cocrystal discovery and development, yielding multiple product opportunities with an accompanying portfolio of intellectual property. Nuformix plc shares are traded on the London Stock Exchange's Official List under the ticker: NFX.L.

About Quotient Clinical www.quotient.com

Quotient Clinical offers unique services - based on its Translational Pharmaceutics® platform - that integrate formulation development, real-time drug product manufacturing and clinical testing, significantly reducing the time and cost of bringing a drug to market.

For more than 25 years, Quotient Clinical has brought innovation to drug product development programs for pharmaceutical and biotechnology customers worldwide. The company is based in purpose-built, fully integrated facilities in the UK, where formulation development, real-time GMP manufacturing and early clinical trials are performed in the same facility. It employs over 350 staff, offering a full range of support services, from study set-up right through to data analysis and reporting.