REG - Immupharma PLC - Lupuzor Update

ImmuPharmaAnnouncement

11/11/2022 07:45

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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™ 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™ clinical program.

 

This included Avion continuing its support to the clinical program of
Lupuzor™ for Lupus, as well as a wider discussion on how the two companies
could potentially  further collaborate.

 

Key highlights:

 

·    Lupuzor™ 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™ for Lupus

 

At the recent meeting in Atlanta, Avion confirmed its support for the
Lupuzor™ 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™) 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™ 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™ and to work with ImmuPharma
to find the optimum way forward for Lupuzor™ 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 (http://www.immupharma.com) )  +44 (0) 207 206 2650

 Tim McCarthy, Chief Executive Officer

 Lisa Baderoon, Head of Investor Relations                         + 44 (0) 7721 413496

                                                                   +44 (0) 203 368 3550 (about%3Ablank)

 SPARK Advisory Partners Limited (NOMAD)

 Neil Baldwin

                                                                   +44 (0) 20 3650 3650

 Stanford Capital Partners (Joint Broker)

 Patrick Claridge, John Howes, Bob Pountney

                                                                   +44 (0) 1483 413500

 SI Capital (Joint Broker)

 Nick Emerson

 

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™, 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
(http://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 (https://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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