Immupharma PLC FDA approves the Lupzuor(TM) PK study (3528I)
12 Agosto 2021 - 1:00AM
UK Regulatory
TIDMIMM
RNS Number : 3528I
Immupharma PLC
12 August 2021
12 August 2021
ImmuPharma PLC
("ImmuPharma" or the "Company")
FDA approves the Lupzuor(TM) PK study
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the
specialist drug discovery and development company, is delighted to
announce that the US Food & Drug Administration ("FDA") has
approved the commencement of the pharmacokinetic ("PK") study, as
part of the new optimised international Phase 3 trial of
Lupuzor(TM).
The PK study is a Phase I study to assess the presence of
Lupuzor(TM) in the body after administration of a single dose. The
study will be carried out in a total of up to 24 healthy male
subjects. Dependent on timing of patient recruitment, we anticipate
that the PK study will take between 8-12 weeks to complete, from
commencement.
Preparations will be made to commence the Phase 3 study,
following completion of the PK study. For the continued late-stage
program development, ImmuPharma and Avion Pharmaceuticals LLC
("Avion"), as part of a joint steering committee, agreed on a
collaborative group consisting of a Board of Key Opinion Leaders
("KOLs") and a leading medical patient advocacy group.
Collectively, this network, due to its in-depth knowledge of the
lupus disease and their access to lupus patient groups, will be
invaluable to the successful outcome of the Phase 3 trial.
ImmuPharma will provide an update on the progress of the PK
study once it has commenced.
Commenting on the announcement, Tim McCarthy, Chairman & CEO
of ImmuPharma said : "We are extremely pleased to see the next
positive steps for Lupuzor(TM), with continued positive dialogue
with the FDA, their approval to commence the PK study and an agreed
clinical and regulatory pathway over the next period. We look
forward to providing further progress updates on the PK study and
ultimately moving Lupuzor(TM) forward into the optimised Phase 3
study, on the successful completion of the PK study."
End
This announcement contains inside information as stipulated
under the UK version of the Market Abuse Regulation no 596/2014
which is part of English law by virtue of the European (withdrawal)
Act 2018, as amended. on publication of this announcement via a
regulatory information service, this information is considered to
be in the public domain.
For further information please contact:
ImmuPharma PLC ( www.immupharma.com )
Tim McCarthy, Chairman and Chief Executive
Officer + 44 (0) 207 152 4080
Dr Tim Franklin, Chief Operating Officer
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin +44 (0) 203 36 8 3550
Stanford Capital Partners (Joint Broker)
Patrick Claridge +44 (0) 203 815 8880
John Howes
Bob Pountney
SI Capital (Joint Broker)
Nick Emerson +44 (0) 1483 413500
4Reliance (Euronext Growth Listing Sponsor) +32 (0) 2 747 02 60
Jean-Charles Snoy
Degroof Petercam (Liquidity Provider) +32 (0) 2 287 95 34
Erik De Clippel
Backstage Communication
Olivier Duquaine +32 (0) 477 504 784
Gunther De Backer +32 (0) 475 903 909
Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM - Euronext Growth: ALIMM) is a
specialty biopharmaceutical company that discovers and develops
peptide-based therapeutics. The Company's portfolio includes novel
peptide therapeutics for autoimmune diseases, metabolic diseases,
anti-infectives and cancer. The lead program, Lupuzor(TM), is a
first-in class autophagy immunomodulator which is in Phase 3 for
the treatment of lupus and preclinical analysis suggest therapeutic
activity for many other autoimmune diseases that share the same
autophagy mechanism of action. ImmuPharma and Avion Pharmaceuticals
signed on 28 November 2019, an exclusive licence and development
agreement and trademark agreement for Lupuzor(TM) to fund a new
international Phase 3 trial for Lupuzor(TM) and commercialise in
the US.
For additional information about ImmuPharma please visit
www.immupharma.co.uk
ImmuPharma's LEI (Legal Entity Identifier) code:
213800VZKGHXC7VUS895.
About Avion Pharmaceuticals LLC
Avion Pharmaceuticals, LLC, is a specialty pharmaceutical
company formed to develop, acquire and market a portfolio of
innovative pharmaceutical products in the Women's Health and other
therapeutic categories aligned with its mission to improve the
quality of patient lives. Avion Pharmaceuticals focuses on
identifying opportunities to develop, acquire and enhance the
market potential of innovative, commercially available therapeutics
and late-stage development drugs to fulfil unmet medical needs. For
more information, visit www.avionrx.com .
About Lupus (Systemic Lupus Erythematosus / SLE)
Lupus is a chronic inflammatory disease which is thought to
affect some 5 million individuals worldwide. The current standard
of care still consists of drugs which have many side-effects and
limited efficacy. Despite the need for an effective treatment, only
one new therapy, namely GlaxoSmithKline's Benlysta, has been
approved to treat the condition over the past 50 years. As such,
there clearly exists an unmet medical need for a drug that has a
strong efficacy and safety profile.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
REAEASPFFESFEFA
(END) Dow Jones Newswires
August 12, 2021 02:00 ET (06:00 GMT)
Immupharma (LSE:IMM)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Immupharma (LSE:IMM)
Gráfica de Acción Histórica
De May 2023 a May 2024