Nuformix Regulatory News (NFX)

Nuformix plc

("Nuformix" or the "Company")

Positive Results for NXP001 Clinical Trial

Proprietary Cocrystal Technology Achieves Bioequivalence to Merck's EMEND®

Cambridge, UK, 30 May 2019: Nuformix (LSE: NFX), the pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs, is pleased to announce positive results in its clinical study for the Company's lead programme NXP001.

NXP001 is in development as a treatment for chemotherapy-induced nausea and vomiting ("CINV"), a large, under-exploited and growing market, which in demographic terms comprises one third of global cancer patients.

In a pilot study in healthy subjects, a proprietary cocrystal-based formulation developed within the NXP001 programme demonstrated bioequivalence to Merck's EMEND® at 125mg both in terms of peak exposure and overall exposure (Cmax and AUC).

The positive results from the trial now enable the Company to:

· Confirm NXP001's potential for development as a treatment for CINV, enabling current and future licensees to launch new products into the £16bn oncology supportive care market

· Trigger a final milestone payment of £2m from its Chinese licensing partner, Newsummit Biopharma, who have commenced product registration in China (Nuformix retains 10% royalty, with remaining milestone payments expected during June 2019)

· Progress on-going discussions for licensing rest of world rights to NXP001 for CINV

· Finalise further product development opportunities for the NXP001 programme to generate additional future value

· Progress its wider portfolio using the Company's proven approach in identifying high-value applications for cocrystal technology

Dr Dan Gooding, CEO, Nuformix plc, said: "We have now delivered a successful outcome in Nuformix's first clinical study. The results have positive implications for our NXP001 programme and provide further validation for Nuformix's overall business model. The results trigger payment of the final £2m milestone from Newsummit Biopharma, advance product registration in China and allow us to progress further discussions for out-licensing NXP001 worldwide.

"Clinical success with NXP001 demonstrates the potential for our wider pipeline. We now seek to replicate our approach of using known drugs to create value with reduced risk and costs of development to build a wider pipeline of innovative therapies. This will be achieved both with in-house programmes and in other collaborations, such as that announced previously with Ebers. We look forward to updating the market as we build on today's success to make progress both technically and commercially across the Nuformix portfolio."

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.

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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 NXP001

Nuformix is developing NXP001 as a treatment for chemotherapy-induced nausea and vomiting ("CINV"). NXP001 is cocrystal-based product containing the NK-1 antagonist, aprepitant. Aprepitant is the active ingredient in Emend® (Merck) marketed globally for the treatment of CINV. CINV is a large, under-exploited and growing market, which in demographic terms comprises one third of global cancer patients. NXP001 will enable new product entries into the oncology supportive care market, currently valued at over £16bn.

About EMEND®

EMEND® (aprepitant, NK-1 antagonist) was developed by Merck and is approved worldwide for the treatment of CINV and post-operative nausea and vomiting (PONV). The NK1-based treatment regimen is globally recognised as the most efficacious in treating CINV and is first-line therapy according to NCCN and NICE guidelines for all highly emetogenic chemotherapy agents.