Immupharma PLC Update: Lupzuor(TM) PK study (9181C)
24 Junio 2021 - 1:00AM
UK Regulatory
TIDMIMM
RNS Number : 9181C
Immupharma PLC
24 June 2021
RNS: RELEASE 24 JUNE 2021
ImmuPharma PLC
("ImmuPharma" or the "Company")
FDA to agree on the Lupzuor(TM) PK study via a written response
to "Type C" meeting as Avion prepares for international Phase 3
trial
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the
specialist drug discovery and development company, announces that
its US Lupuzor(TM) partner, Avion Pharmaceuticals ("Avion") has
received a positive response from the US Food & Drug
Administration ("FDA") for a "Type C" meeting. The FDA has advised
that they do not require a formal face to face meeting and will
provide their written response to Avion approximately by the end of
July 2021.
As noted in our previous announcement of 9 February, this is the
final guidance meeting at which the FDA will review the proposed
methodology of the pharmacokinetic ("PK") study. This study was
requested by the FDA as part of the new optimised international
Phase 3 trial of Lupuzor(TM) in systemic lupus erythematosus
("SLE"), a potentially life-threatening autoimmune disease.
ImmuPharma will provide an update as soon as Avion has received
the written response from the FDA and advised ImmuPharma of the
next steps and timetable towards commencing the Phase 3 trial this
year.
Commenting on the announcement, Tim Franklin, COO of ImmuPharma
said :
"We continue to acknowledge the FDA's support following
constructive meetings and feedback this year with our partner
Avion. ImmuPharma and Avion are fully committed to commencing the
Lupuzor(TM) Phase 3 trial in Lupus patients this year. Again, we
reiterate Lupuzor's(TM) unique mechanism of action and robust
safety profile to date, which we believe will position Lupuzor(TM)
as a first line therapy to many Lupus sufferers globally."
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.
Ends
For further information please contact:
ImmuPharma PLC ( www.immupharma.com )
Tim McCarthy, Chairman + 44 (0) 207 152 4080
Dimitri Dimitriou, Chief Executive Officer
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin
Stanford Capital Partners (Joint Broker) +44 (0) 203 36 8 3550
Patrick Claridge
John Howes
Bob Pountney +44 (0) 203 815 8880
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.
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RESEANKDAADFEFA
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