TIDMIMM
RNS Number : 1192G
Immupharma PLC
11 November 2022
11 November 2022
ImmuPharma PLC
("ImmuPharma" or the "Company")
Avion confirms its continued support to the Lupuzor(TM) clinical
program in Lupus
whilst exploring broader collaboration opportunities
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is pleased to update the market on a recent
meeting in Atlanta, USA with our US partner, Avion Pharmaceuticals,
LLC ("Avion") for strategic discussions around ImmuPharma's
Lupuzor(TM) clinical program.
This included Avion continuing its support to the clinical
program of Lupuzor(TM) for Lupus, as well as a wider discussion on
how the two companies could potentially further collaborate.
Key highlights:
-- Lupuzor(TM) for Lupus clinical program to be redesigned on
key protocols following written response from FDA, in order to
enhance the probability of success.
-- Potential of product sales revenues for ImmuPharma by
introducing certain Avion drugs into the European market.
Lupuzor(TM) for Lupus
At the recent meeting in Atlanta, Avion confirmed its support
for the Lupuzor(TM) clinical program in Lupus. This follows on from
the receipt in September of the written response from the Food and
Drug Administration ("FDA") to the Type C meeting.
In its written response, the FDA provided significant and
extremely valuable guidance on the study protocol, that could be
amended, to improve the regulatory outcome. This primarily focussed
on a recommendation to explore higher dosing levels (given the
robust safety profile of Lupuzor(TM)) than have been used in the
clinical program to date, to enhance the probability of meeting the
primary endpoint of statistically significant efficacy. The
ImmuPharma/Avion team, together with external advisors, are
preparing a proposed updated clinical programme. This is
considering either a Phase 2 dose ranging study to identify the
optimum dose level, followed by a Phase 3 study with that optimum
dose; or alternatively a Phase 2/3 adaptive study which would
encompass the same dose ranging, albeit within one continuous
study. The chosen route will be agreed with the FDA. Further
details on the study design and progress of the program will be
communicated to the market once the FDA has been consulted and
their response has been provided.
Potential Distribution Agreement
We have agreed to explore the opportunity of a mutually
beneficial route to allow ImmuPharma to introduce certain Avion
products into the European market. If this is successful, this
would generate top-line product sales revenue for the first time in
ImmuPharma's history and contribute net positive cash flow to the
Company.
We in turn, have identified an established European partner who
could provide the infrastructure to market and distribute the
products.
Discussions are to be progressed as to the legal, regulatory and
commercial aspects of such a collaboration and we will provide
further details in due course.
Commenting on the announcement, Tim McCarthy, CEO of ImmuPharma,
said:
"We have had extremely positive discussions with Avion over the
last month and, following receipt of the written response from the
FDA, we have agreed to redesign the clinical program for
Lupuzor(TM) to encompass the recommendations from the FDA, with a
view to enhancing the probability of success. In addition, our
discussions have developed the potential of a much broader
collaboration whereby we would be working in partnership to
introduce certain Avion products into the European market."
Responding, Art Deas, CEO of Avion, said:
"We continue to be very supportive of Lupuzor(TM) and to work
with ImmuPharma to find the optimum way forward for Lupuzor(TM) in
its clinical program . As a supportive and involved partner with
ImmuPharma, we will continue to look at new initiatives to create
value by working effectively and diligently with the team at
ImmuPharma."
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 ) +44 (0) 207 206 2650
Tim McCarthy, 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, 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 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
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
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.
ImmuPharma's LEI (Legal Entity Identifier) code :
213800VZKGHXC7VUS895.
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