Nuformix Regulatory News (NFX)

Nuformix plc

("Nuformix" or the "Company")

MHRA approval to commence NXP001 Human Pharmacokinetics Studies

Cambridge, UK, 27 February 2019: Nuformix (LSE: NFX), the pharmaceutical development company using cocrystal technology to unlock the therapeutic potential of approved small molecule drugs, announces it has received approval from the UK Medicines and Healthcare Products Regulatory Agency ("MHRA") to commence human pharmacokinetics studies for the Company's lead asset NXP001. The approval allows Nuformix to initiate the first dosing of NXP001 in an open-label study to compare the bioavailability of NXP001 to Merck's EMEND® in healthy subjects.

Nuformix is developing NXP001 as a treatment for chemotherapy-induced nausea and vomiting ("CINV"). CINV is a large, under-exploited and growing market, which in demographic terms comprises one third of global cancer patients. The primary objective of the study is to investigate the pharmacokinetics and bioavailability of single oral doses of NXP001. Dosing will commence in March 2019, with results expected by end H1 2019.

Dr Dan Gooding, CEO, Nuformix plc, said: "Although expected, receiving approval to advance our first programme into human studies is a major step forward for our Company and our pipeline. The MHRA's decision validates the speed to clinic of our cocrystal approach without the need for further safety data and sets a precedent for our broader pipeline. Completion of these studies will allow us to rapidly progress NXP001 as a cancer supportive care treatment. In addition to triggering the payment of the final £2m milestone by our China market partner and advancing product registration in China, the approval and successful completion of the study will significantly increase Nuformix's ability to secure further commercial partnerships in other territories, with discussions on-going with multiple parties."

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.