TIDMIMM
RNS Number : 3843O
Immupharma PLC
09 February 2021
9 February 2021
ImmuPharma PLC
("ImmuPharma" or the "Company")
Lupuzor(TM) scheduled to commence international Phase 3 trial in
Lupus patients in H2 2021
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the
specialist drug discovery and development company, announces an
update in respect to the new optimised international Phase 3 trial
of Lupuzor(TM) in systemic lupus erythematosus ("SLE"), a
potentially life-threatening auto-immune disease.
As indicated in the 20 November 2020 announcement, Avion
Pharmaceuticals ("Avion"), ImmuPharma's licensing partner for
Lupuzor(TM), met with the US Food & Drug Administration ("FDA")
on 4 December 2020 for a Type 'A' Meeting Request.
Avion has received feedback from the FDA, and has now advised
ImmuPharma of the programme of activities in respect to its
commitment to schedule next steps.
In response to the FDA input, Avion, in partnership with
ImmuPharma, has plans to develop and validate a bioanalytical
assay, to confirm the clinical pharmacology and pharmacokinetic
("PK") characterizations of Lupuzor(TM), prior to commencement of
the Phase 3 trial.
A final guidance meeting between Avion and the FDA is being
planned at which Avion will submit the methodology for assessing PK
as part of the Phase 3 trial. This meeting, which is expected to
take place in Q2, will also confirm previous submissions to FDA on
the study design, clinical end points and approval process.
As indicated in the 20 November 2020 announcement, ImmuPharma
initiated the production of a new batch of Lupuzor(TM) clinical
trial material specifically for the Phase 3 trial and it can be
confirmed that this will be ready for the start of the trial.
As part of the FDA feedback from the meeting on 4 December 2020,
it has been clarified that a Special Protocol Assessment ("SPA")
will not be applicable and a conditional approval of Lupuzor(TM),
whilst the Phase 3 trial is underway, has not been confirmed at
this time.
Commenting on the announcement, Dimitri Dimitriou, CEO of
ImmuPharma said :
"We are extremely pleased to see the positive progress of
Lupuzor(TM) towards the commencement of the international Phase 3
trial with Avion. We will continue to work closely with Avion over
the next period to ensure the start of the Phase 3 study remains on
schedule for H2 2021."
Art Deas, Chief Executive Officer, Avion Pharmaceuticals added:
"Following continued positive dialogue with the FDA and with an
agreed clinical and regulatory pathway over the next period, we
look forward to moving Lupuzor(TM) ahead later this year."
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 + 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.
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.
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