Nuformix PLC MHRA approval for NXP001 (2032R)
27 Febrero 2019 - 1:01AM
UK Regulatory
TIDMNFX
RNS Number : 2032R
Nuformix PLC
27 February 2019
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(R) 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
GBP2m 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.
Enquiries:
Nuformix plc
Dr Dan Gooding, Chief Executive
Officer +44 (0)1223 627222
Optimum Strategic Communications
Mary Clark, Supriya Mathur +44 (0) 203 950
Email: nuformix@optimumcomms.com 9144
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.
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END
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