Immupharma PLC FDA submission for Special Protocol Assessment (0862U)
27 Julio 2020 - 1:00AM
UK Regulatory
TIDMIMM
RNS Number : 0862U
Immupharma PLC
27 July 2020
27 July 2020
ImmuPharma plc
("ImmuPharma" or the "Company")
Submission to the FDA for a Special Protocol Assessment
(SPA)
for the forthcoming international Phase III trial of Lupuzor(TM)
in Lupus Patients
ImmuPharma plc (LSE:IMM) (Euronext Growth Brussels: ALIMM), the
specialist drug discovery and development company, announces an
important regulatory milestone in preparation for the new optimised
international Phase III trial of Lupuzor(TM) for systemic lupus
erythematosus ("SLE") a potentially life-threatening auto-immune
disease.
ImmuPharma's licensing partner for Lupuzor(TM), Avion
Pharmaceuticals LLC ("Avion"), has submitted a Special Protocol
Assessment ("SPA") request to the US Food & Drug Administration
("FDA"). SPA is a process in which sponsors reach agreement with
the FDA on the design and size of clinical trials such that they
adequately address scientific and regulatory requirements for a
study that could support marketing approval. The previous Phase III
clinical trial of Lupuzor(TM) in SLE was also carried out under
ImmuPharma's SPA. The review period for an SPA request is up to 45
days.
On 28 November 2019, ImmuPharma and Avion signed an exclusive
licence and development agreement and trademark agreement for
Lupuzor(TM), with Avion agreeing to fund a new international Phase
III trial and commercialising Lupuzor(TM) in the US. Since then,
both companies have been working closely on the clinical trial
design and strategy, bolstered by consultation with an eminent
group of key opinion leaders. This tripartite Phase III protocol
development approach provided thorough and detailed support for
developing the most relevant clinical trial for Lupuzor(TM) in SLE
patients. Data and results from the first Phase III clinical study
were analysed and considered in detail and, as a result, a new
optimised international Phase III study protocol has been finalised
and is now the subject of the SPA request to FDA.
The new Phase III study design will be communicated to the
market at a later date, once agreed with the FDA, and in due course
will appear on 'clinicaltrials.gov'.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014. ("MAR")
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 +44 (0) 203 36 8 3550
Stanford Capital Partners (Joint Broker)
Patrick Claridge, John Howes +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
and cancer. The lead program, Lupuzor(TM), is a first-in class
autophagy immunomodulator which is in Phase III for the treatment
of systemic lupus erythematosus (lupus / SLE). Lupus is an
autoimmune disease which if left untreated can be fatal.
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 III
trial for Lupuzor(TM) and commercialise in the US. For additional
information about ImmuPharma please visit www.immupharma.com.
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
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.
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 .
Special Protocol Assessment (SPA)
SPA is a process in which sponsors - in this case, Avion, may
ask to meet with the FDA to reach agreement on the design and size
of certain clinical trials to determine if they adequately address
scientific and regulatory requirements for a study that could
support marketing approval. An SPA agreement indicates concurrence
by the FDA with the adequacy and acceptability of specific critical
elements of overall protocol design (e.g., entry criteria, dose
selection, endpoints, and planned analyses) for a study intended to
support a future marketing application. These elements are critical
to ensuring that the trial conducted under the protocol can be
considered an adequate and well-controlled study that can support
marketing approval. Feedback on these issues provides the greatest
benefit to sponsors in planning late-phase development strategy.
(Source: https://www.fda.gov/media/97618/download ).
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END
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