Immupharma PLC Update on Lupuzor (2084Q)
June 27 2022 - 2:00AM
UK Regulatory
TIDMIMM
RNS Number : 2084Q
Immupharma PLC
27 June 2022
RNS: RELEASE 27 JUNE 2022
ImmuPharma PLC
("ImmuPharma" or the "Company")
Avion seeks final regulatory guidance as it prepares for the
start of the international Phase 3 trial of Lupuzor(TM) in Lupus
patients
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is delighted to announce that, having met all
the Food and Drug Administration's ("FDA") requirements, Avion
Pharmaceuticals ("Avion"), its US partner, has confirmed that it
has sought final regulatory guidance from the FDA, as it actively
prepares for the start of the international Phase 3 trial of
Lupuzor(TM) in Lupus patients.
This confirmation follows a recent meeting between the two
companies at Avion's US headquarters in Atlanta, Georgia.
Further to our last update on 4(th) May 2022, Avion has
submitted, via a Type C Meeting, the positive results from the
Lupuzor(TM)/P140 Pharmacokinetic ("PK") study to the FDA.
As noted in previous announcements, the PK study required by the
FDA, met all the key endpoints and (in line with all human dosing
to date), demonstrated that P140 was safe and well tolerated across
all doses and in all subjects .
As previously disclosed, as an integral part of the licence and
development agreement for Lupuzor(TM) entered into between Avion
and ImmuPharma, the new international Phase 3 trial for Lupuzor(TM)
is being funded by Avion, who have the exclusive rights to
commercialise Lupuzor(TM) in the US, whilst the rest of the world
rights remain with ImmuPharma.
Commenting on the announcement, Tim McCarthy, Chief Executive
Officer, said: "This final step by Avion is a pivotal moment for
the Company and for the progress of Lupuzor(TM) towards becoming a
groundbreaking new treatment for Lupus patients. Lupuzor's(TM)
unique mechanism of action and robust safety profile will, we
believe, position Lupuzor(TM) as a first line therapy to many Lupus
sufferers globally."
Art Deas, Chief Executive Officer of Avion further commented: "
Having met all the FDA's requirements, we are delighted to be
seeking the FDA's final guidance on moving Lupuzor(TM) forward into
the new international Phase 3 trial. We anticipate Lupuzor(TM)
becoming the leading product in our portfolio and that it will be
instrumental in bringing an innovative treatment to Lupus patients,
which is not currently available on the market today."
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 and Chief Executive
Officer +44 (0) 207 206 2650
Dr Tim Franklin, Chief Operating Officer
Lisa Baderoon, Head of Investor Relations
& Non-Executive Director + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin +44 (0) 203 36 8 3550
Stanford Capital Partners (Joint Broker)
Patrick Claridge, John Howes, Bob Pountney +44 (0) 20 3650 3650
SI Capital (Joint Broker)
Nick Emerson +44 (0) 1483 413500
Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM) is a specialty biopharmaceutical
company that discovers and develops peptide-based therapeutics. The
Company's portfolio includes novel peptide therapeutics for
autoimmune diseases and anti-infectives. 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.
For additional information about ImmuPharma please visit
www.immupharma.co.uk
ImmuPharma's LEI (Legal Entity Identifier) code:
213800VZKGHXC7VUS895.
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
two therapies, namely GlaxoSmithKline's Benlysta and more recently,
Astra Zeneca's Saphnelo, have 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.
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