Nuformix PLC Positive Results for NXP001 Clinical Trial (5799A)
30 Mayo 2019 - 1:01AM
UK Regulatory
TIDMNFX
RNS Number : 5799A
Nuformix PLC
30 May 2019
Nuformix plc
("Nuformix" or the "Company")
Positive Results for NXP001 Clinical Trial
Proprietary Cocrystal Technology Achieves Bioequivalence to
Merck's EMEND(R)
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(R) at 125mg both in
terms of peak exposure and overall exposure (C(max) 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 GBP16bn oncology supportive care market
-- Trigger a final milestone payment of GBP2m 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 GBP2m 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.
Enquiries:
Nuformix plc
Dr Dan Gooding, Chief Executive
Officer +44 (0)1223 627222
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(R) (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 GBP16bn.
About EMEND(R)
EMEND(R) (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.
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END
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