Nuformix Regulatory News (NFX)

Nuformix plc

("Nuformix" or the "Company")

Nuformix Reports Results from Novel Pre-Clinical Trial in IPF for NXP002 Programme

Data show Nuformix Investigational Candidates (NXP002) outperform current standard of care

Cambridge, UK, 3rd December 2018: Nuformix, the pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs, announces results from the completion of its innovative pre-clinical trial for its NXP002 fibrosis programme in human idiopathic pulmonary fibrosis ('IPF') against standard of care[1].

Multi-patient tissue studies were performed in partnership with Newcastle University, UK using a leading-edge human tissue trial model that closely replicates the clinical disease:

·  Data demonstrates NXP002 candidates strongly inhibit fibrosis ex-vivo, even in very severely fibrotic patient tissue, giving strong support for treating IPF and other fibrotic lung conditions

· In addition, NXP002 demonstrated specific action measured against key inflammatory targets

· NXP002 out-performed current standard of care treatment, Esbriet ® (pirfenidone)

In partnership with the Newcastle University Fibrosis Research Group, UK, these results are the first of their kind to be published. Despite this being a challenging model of end-stage disease, the outcomes are considered highly positive and a portent for wider applications in other fibrotic lung conditions.

Dr Dan Gooding, CEO, Nuformix plc, said: "Despite the advent of new treatments, life expectancy has not really changed for patients diagnosed with IPF. Few patients respond to current treatments and have to tolerate severe side effects that dramatically impact quality of life - severe vomiting on one therapy or severe diarrhoea on the other. This promising data gives us confidence in our ability to both inhibit fibrosis and attenuate inflammation in patients without these side effects.

"Newcastle University use a highly innovative new human tissue model, which has the potential to become the new gold standard for pre-clinical studies. These findings are important for IPF patients and show our NXP002 programme can play an important role in improving on current treatment options and extending both life and its quality." 

Nuformix will now seek to optimise delivery of a candidate within its NXP002 programme to maximise efficacy and tolerability using its patented novel drug forms before moving into patient studies.

Market Abuse Regulation (MAR) Disclosure. Certain information contained in this announcement would have been deemed inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 until the publication of this announcement via a Regulatory Information Service and accordingly, this inside information is now considered to be in the public domain.

Enquiries:

About Nuformix plc www.nuformix.com 

Nuformix is a pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs. Nuformix's 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.

Nuformix has created an IP portfolio 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 2009 and has invested in pharmaceutical cocrystal R&D, establishing world-class capability and know-how in cocrystal discovery and development, yielding multiple product opportunities. 

Nuformix plc shares are traded on the London Stock Exchange's Official List under the ticker: NFX.L.

About Fibrosis

Fibrotic disease is typically associated with high patient mortality, increasing prevalence and a lack of safe and effective treatments. Whilst, fibrosis treatments are in their infancy the emerging lung fibrosis market demonstrates their blockbuster potential. Markets for other fibrotic conditions are under-developed, with large and growing patient populations (e.g. the global liver disease market is predicted to reach $12.1 billion by 2022). IPF is classified as a rare disease, and presents a global commercial market that is forecast to grow to $5bn by 2025. 

Nuformix filed an additional patent in September 2018 relating to NXP002 products in order to capture a wider range of options in the treatment of fibrosis given its broad anti-fibrotic potential with relevance to unmet needs in multiple life-threatening conditions.

About the IPF Model

Ground-breaking research at Newcastle University, UK has validated the use of post-transplant human fibrotic lung tissue to evaluate new therapies. The model uniquely represents an 'in-patient' scenario unlike any current pre-clinical model, where fibrotic tissue is kept alive and functional allowing the impact of prevention of disease progression to be accurately assessed. The data are generated from patients with end-stage IPF, presenting high fibrosis in the lung tissue where the only chance of survival was a lung transplant. The resulting data are the first to be reported in multiple patient IPF lung tissues, yet offers patients the possibility of reduced side-effects, which are currently so severe that roughly 40% of patients cease treatment.